FDA Device Registration & Listing · Minneapolis, MN, US · Registration 2183787
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2016-11-21 |
| OSR | Pacemaker/Icd/Crt Non-Implanted Components | Unknown | Class 3 | N/A | 2022-04-15 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | Class 3 | N/A | 2022-04-15 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2011-03-13 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2016-05-04 |
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Unknown | Class 3 | N/A | 2014-12-10 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2013-01-31 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2009-07-01 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2009-07-01 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2018-08-23 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2011-03-13 |
| DTD | Pacemaker Lead Adaptor | Cardiovascular | Class 2 | 870.3620 | 2009-07-01 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | Class 3 | N/A | 2014-12-10 |
| NVY | Permanent Defibrillator Electrodes | Unknown | Class 3 | N/A | 2014-12-10 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3011823740 | Greatbatch Medical S. de R.L. de C.V. | Tijuana Baja California, MX |
| 3007882731 | Greatbatch Medical, S. de R.L. de C.V. | Tijuana Baja California, MX |
| 3010326622 | Centro de Construccion de Cardioestimuladores del Uruguay S.A. | Montevideo, UY |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K101883 | St Jude Medical | 6F ENGAGE/ENGAGE TR INTRODUCER | 2010-09-07 |
| K034025 | Nmt Medical, Inc. | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | 2004-03-26 |
| K122854 | Arrow International (Subsidiary of Teleflex Inc.) | ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER | 2013-01-04 |
| K233691 | Acutus Medical, Inc. | FlexCath Cross Transseptal Solution | 2023-12-17 |
| K915078 | North American Instrument Corp. | MORSE HEMOSTATIC CATHETER INTRODUCER SET | 1992-06-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0783-2020 | Abbott Medical | 2 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 |
| Z-0789-2020 | Abbott Medical | 2 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. |
| Z-0033-2018 | St Jude Medical Inc. | 3 | Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.
The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm. |
| Z-0002-2007 | Guidant Corporation | 3 | Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. |
| Z-0003-2018 | St Jude Medical Inc. | 3 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q
Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017689643 | CARDIOVIA Ltd. | Nazareth Northern, IL |
| 3041086754 | PULNOVO MEDICAL (WUXI) CO., LTD. | Wuxi Jiangsu, CN |
| 3013764800 | B. BRAUN MEDICAL INC. | Allentown, PA, US |
| 2020394 | BARD PERIPHERAL VASCULAR, INC. | TEMPE, AZ, US |
| 3016904853 | SAINT JONES MANAGEMENT LP EOOD | Sofia Sofia-Grad, BG |
2183787 when referencing this establishment in official correspondence.