Product code DSQ ยท Class 3
Ventricular (Assist) Bypass
0510(k)s in 12 months (0 all time)
8recalls in 12 months (131 all time)
1recalls that name a 510(k)
Top companies in DSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| HeartWare Inc | 0 | 75 |
| Thoratec Corp | 0 | 42 |
| Abiomed, Inc. | 0 | 5 |
| Medtronic Inc | 0 | 3 |
| BERLIN HEART GMBH | 0 | 2 |
| Abbott | 0 | 1 |
| Datascope Corporation | 0 | 1 |
| Jarvik Heart Inc | 0 | 1 |
| Thoratec Switzerland GMBH | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205.
For use as a bridge-to-cardiac transplantation in patients who are at risk of d Open, Classified |
DSQ | None listed |
| Jun 11, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HVAD).
Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205.
Intended for use as a bridge to cardiac transplantation in patients who are at risk of dea Open, Classified |
DSQ | None listed |
| Jun 10, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. Open, Classified |
DSQ | None listed |
| Jun 8, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.
Product Usage:
For use as a bridge-to-cardiac transplantation in patient who ar Open, Classified |
DSQ | None listed |
| May 14, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Product Usage:
Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited t Open, Classified |
DSQ | None listed |
| Feb 25, 2015 | HeartWare Inc HeartWare Ventricular Assist System (HeartWare Controller)
Product Usage:
For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricula Terminated |
DSQ | None listed |
| May 14, 2014 | HeartWare Inc HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery
For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage Terminated |
DSQ | None listed |
| Apr 23, 2014 | HeartWare Inc Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation Heart Mate II Pocket Controllers removed from packaging
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequat Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation HeartMate II LVAD Pump and Pock Controller Kit;
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on i Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation HeartMate II System Controller
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is some Terminated |
DSQ | None listed |
| Mar 21, 2014 | Thoratec Corporation HeartMate II Implant Kit with Pocket Controller;
with sealed grafts (NAm)
with sealed grafts (EU)
Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when th Terminated |
DSQ | None listed |
| Jul 29, 2013 | HeartWare Inc Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Terminated |
DSQ | None listed |
| May 14, 2013 | Heartware Inc Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Terminated |
DSQ | None listed |
| Mar 23, 2012 | Thoratec Corporation HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief.
The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in t Terminated |
DSQ | None listed |
| Oct 13, 2010 | Thoratec Corp HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/ Terminated |
DSQ | None listed |
| Mar 4, 2010 | Abiomed, Inc. Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA.
Intended to provide complete short-term support of the left and/or right sides of the Terminated |
DSQ | None listed |
| Nov 24, 2009 | Thoratec Corp HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems.
The HeartMate II and the HeartMate XVE LV Terminated |
DSQ | None listed |
| Sep 16, 2009 | Abiomed, Inc. iPulse Circulatory Support System
Catalog number: 0036-0010
The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovas Terminated |
DSQ | None listed |
| Sep 1, 2009 | Abiomed, Inc. Abiomed AB5000 Portable Driver
Catalog number: 0025-0000
The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunctio Terminated |
DSQ | None listed |
| Dec 22, 2008 | Thoratec Corp Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139.
Product is manufactured and distributed by Thoratec Corporation,
Pleasant, CA. Terminated |
DSQ | None listed |
| Nov 21, 2007 | Thoratec Corp Thoratec Implantable Ventricular Assist Device (IVAD pump)
(Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588 Terminated |
DSQ | None listed |
| Jul 27, 2007 | Thoratec Corp Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000. Terminated |
DSQ | None listed |
| Jul 27, 2007 | Thoratec Corp Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system Terminated |
DSQ | None listed |
| Mar 7, 2007 | Abiomed, Inc. AB5000 Console Circulatory Support System
Catalog Number: 0015-0000 Terminated |
DSQ | None listed |
| Feb 10, 2007 | Thoratec Corp Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Ple Terminated |
DSQ | None listed |
| Oct 4, 2006 | Thoratec Corp Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System,
Model Number(s): Catalogue numbers:
#100118-- Short, 14mm graft;
#100121-- Long, 14mm graft;
#10012 Terminated |
DSQ | None listed |
| Oct 3, 2006 | Thoratec Corp Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000
Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588 Terminated |
DSQ | None listed |
| Sep 11, 2003 | Abiomed, Inc. BVS 5000t Bi-Ventricular Support System Transport/Backup Console
Catalog Number: 0050-000 Terminated |
DSQ | None listed |
| Mar 27, 2003 | Thoratec Corp HeartMate Stroke Volume Limiter (SVL)
Catalog # 1295 Terminated |
DSQ | None listed |
| Jan 30, 2003 | Thoratec Corp Thoratec Sterile LVAD Pneumatic Lead 5'' ;
Model/Product Number: 20010-0000-108 Terminated |
DSQ | None listed |
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