FDA Device Registration & Listing · CARSON, CA, US · Registration 2024311
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2026-03-31 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2016-01-27 |
| DRA | Catheter, Steerable | Cardiovascular | Class 2 | 870.1280 | 2026-02-11 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2014-08-21 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-31 |
| NCX | System, Hypothermia, Intravenous, Cooling | Cardiovascular | Class 2 | 870.5900 | 2013-05-10 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2017-11-08 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2007-10-17 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2014-04-04 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2022-03-31 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2014-03-31 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2014-03-31 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2020-03-27 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2013-05-08 |
| EPE | Brush, Cleaning, Tracheal Tube | Anesthesiology | Class 1 | 868.5795 | 2014-04-04 |
| DXE | Catheter, Embolectomy | Cardiovascular | Class 2 | 870.5150 | 2014-04-04 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2014-04-04 |
| KEW | Slides, Microscope | Pathology | Class 1 | 864.3010 | 2014-04-04 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | Class 3 | N/A | 2014-03-31 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2021-02-02 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2016-07-08 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2016-07-08 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2013-05-06 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2016-07-08 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2021-02-02 |
| MUD | Oximeter, Tissue Saturation | Cardiovascular | Class 2 | 870.2700 | 2026-02-10 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2007-10-17 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2023-09-06 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2014-04-04 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2021-02-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2026-03-31 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2026-03-31 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2021-02-02 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-03-23 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2016-01-27 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2025-06-03 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2014-04-04 |
| IPM | Cover, Limb | Physical Medicine | Class 1 | 890.3025 | 2014-04-04 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2014-04-04 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2014-04-04 |
| KYW | Container, Liquid Medication, Graduated | General Hospital | Class 1 | 880.6430 | 2014-04-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2022-12-20 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2022-12-20 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2024-08-06 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2020-03-27 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | Class 2 | 892.1560 | 2013-05-06 |
| ORD | Optical Coherence Tomography, Intravascular Catheter | Cardiovascular | Class 2 | 870.1200 | 2013-05-06 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2025-03-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-03-04 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2013-05-06 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2014-04-04 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2014-04-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2014-04-02 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2016-01-27 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2016-01-27 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2016-01-27 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2016-01-27 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2016-01-27 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2022-12-20 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2022-12-20 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2022-12-20 |
| DYG | Catheter, Flow Directed | Cardiovascular | Class 2 | 870.1240 | 2014-04-04 |
| CFG | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | Clinical Chemistry | Class 1 | 862.1465 | 2025-03-04 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2019-12-12 |
| PCU | Pancreatic Stent, Covered, Metallic, Removable | Gastroenterology, Urology | Class 2 | 876.5015 | 2015-05-01 |
| LQE | Implant, Corneal, Refractive | Unknown | Class 3 | N/A | 2015-05-01 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | Microbiology | Class 1 | 866.2660 | 2006-03-20 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2024-08-06 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2024-08-06 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2024-06-17 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2013-05-08 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2013-05-08 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2013-05-08 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2021-02-02 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Unknown | Class 3 | N/A | 2017-12-12 |
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | Gastroenterology, Urology | Class 2 | 876.5510 | 2026-03-31 |
| EPP | Splint, Nasal | Ear, Nose, Throat | Class 1 | 874.5800 | 2014-04-04 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2021-02-02 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2014-04-02 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2024-08-06 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2014-08-21 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2014-08-21 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | Class 2 | 882.1870 | 2014-08-21 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2013-05-10 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2016-01-27 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2024-08-22 |
| DRA | Catheter, Steerable | Cardiovascular | Class 2 | 870.1280 | 2025-03-04 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-03-04 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2013-05-08 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2013-05-06 |
| GDW | Staple, Implantable | General, Plastic Surgery | Class 2 | 878.4750 | 2013-05-06 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2014-04-04 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2013-05-08 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2013-04-25 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2025-03-04 |
| NKM | Mitral Valve Repair Devices | Unknown | Class 3 | N/A | 2026-02-11 |
| JYS | Perforator, Ear-Lobe | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-05-10 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2026-03-23 |
| EFQ | Gauze/Sponge, Internal | Unknown | Class U | N/A | 2014-04-04 |
| NCX | System, Hypothermia, Intravenous, Cooling | Cardiovascular | Class 2 | 870.5900 | 2013-05-10 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2023-12-21 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2014-04-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2022-12-20 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2022-12-20 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2024-01-05 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-06 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-06 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-06 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-08-06 |
| MUD | Oximeter, Tissue Saturation | Cardiovascular | Class 2 | 870.2700 | 2026-02-10 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Unknown | Class 3 | N/A | 2016-01-27 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2013-05-10 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-06-13 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2025-06-13 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2014-04-04 |
| LYC | Bone Grafting Material, Synthetic | Dental | Class 2 | 872.3930 | 2013-05-08 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2014-04-04 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005735987 | PARTER STERILIZATION SERVICES | Ontario, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K033736 | Concentric Medical, Inc. | MERCI RETRIEVER, MODELS 90065, 90066 | 2004-08-11 |
| K884337 | Catheter Research C/O Burditt, Bowles & Radzius | MICRO-GUIDE SYSTEM | 1989-01-05 |
| K162925 | Acutus Medical, Inc. | AcQGuide Steerable Sheath | 2017-04-06 |
| K221397 | ABBOTT MEDICAL | MitraClip G4 Steerable Guide Catheter | 2022-09-28 |
| K833646 | Edward Weck, Inc. | PULSATRON NERVE LOCATOR/STIMULATOR | 1984-02-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0023-2020 | Stryker Instruments Div. of Stryker Corporation | 2 | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. |
| Z-0024-2020 | Stryker Instruments Div. of Stryker Corporation | 2 | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. |
| Z-0039-2022 | ZOLL Circulation, Inc. | 2 | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237 |
| Z-0040-2022 | ZOLL Circulation, Inc. | 2 | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3 |
| Z-0041-2022 | ZOLL Circulation, Inc. | 2 | ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3022392708 | INFINITY NEURO, LLC | Lake Forest, CA, US |
| 3014590708 | IMPERATIVE CARE INC. | Campbell, CA, US |
| 3014211783 | ALEMBIC LLC | Mountain View, CA, US |
| 3008853977 | Stryker Neurovascular | Fremont, CA, US |
| 3015615738 | Penumbra Inc. | Salt Lake City, UT, US |
2024311 when referencing this establishment in official correspondence.