FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3009756153
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2024-02-02 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Clinical Chemistry | Class 1 | 862.2050 | 2022-05-12 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2021-07-01 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2023-12-16 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2023-12-16 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2022-10-20 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2021-08-23 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2024-10-19 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2022-03-01 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2022-03-01 |
| PXB | Percutaneous Introducer Kit | General Hospital | Class 2 | 880.5570 | 2024-04-16 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2026-05-07 |
| HKY | Tonometer, Manual | Ophthalmic | Class 2 | 886.1930 | 2024-06-18 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-10-19 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-11-19 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-11-19 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2020-05-05 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | Class 2 | 870.1250 | 2020-09-24 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2021-08-23 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-01-02 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-09-24 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2021-08-23 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2021-08-23 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2016-01-27 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2015-02-06 |
| OFC | Catheter Introducer Kit | Cardiovascular | Class 2 | 870.1340 | 2024-04-16 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-11-03 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-24 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2026-03-24 |
| GCQ | Endoscope, Flexible | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-24 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-08-23 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2021-08-23 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2016-11-30 |
| HKY | Tonometer, Manual | Ophthalmic | Class 2 | 886.1930 | 2021-07-26 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2023-11-15 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2021-08-23 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2020-05-01 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2022-05-16 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2025-01-02 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2020-02-27 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2021-08-23 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K792141 | Pharmaseal Div., Baxter Healthcare Corp. | CONTINUOUS FLUSH DEVICE | 1979-12-05 |
| K924661 | Baxter Healthcare Corp | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER | 1993-04-08 |
| K043580 | Chestnut Medical Technologies, Inc. | ALLIGATOR RETRIEVAL DEVICE (ARD) | 2005-03-24 |
| K982883 | Medtronics Interventional Vascular | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | 1998-09-04 |
| K132420 | Reflow Medical | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | 2013-09-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2010 | Penumbra Inc. | 2 | Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA.
Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Z-0003-2014 | Cordis Corporation | 2 | Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. |
| Z-0009-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter |
| Z-0010-04 | Bard Peripheral Vascular | 2 | Conquest Balloon Dilation Catheters
Model/Catalog Number CQ 75124 |
| Z-0010-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3038791046 | LIQUET MEDICAL INC. | Glen Allen, VA, US |
| 3013134719 | HEXACATH | Rueil Malmaison Ile-de-France, FR |
| 3026567963 | ENDOVASCULAR ENGINEERING, INC. | Menlo Park, CA, US |
| 3021067373 | VVT MED Ltd | Kfar Saba Central, IL |
| 3019525998 | VASCUPATENT MEDICAL (SHENZHEN) CO., LTD | Shenzhen Guangdong, CN |
3009756153 when referencing this establishment in official correspondence.