Abbott Vascular Devices
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
The Emboshield Embolic Protection System Ref K052454
Regimes: 510(k) Registry: 510(k)- Regimes: PMA Registry: PMA
Starclosure Se Vascular Closure System Ref P050007
Regimes: PMA Registry: PMA
FDA recalls
2003
- 21 Jul 2003 Z-1141-03 Unclassified (pre-2012) Terminated The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
Full distribution text
- 21 Jul 2003 Z-1141-03 Unclassified (pre-2012) Terminated The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.
Frequently asked questions
How many devices does Abbott Vascular Devices have in the registry?
The registry currently lists 4 devices for Abbott Vascular Devices. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Vascular Devices's devices?
Among its 4 most recently registered devices, Abbott Vascular Devices has devices listed in FDA 510(k) (2 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Abbott Vascular Devices's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Abbott Vascular Devices's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Vascular Devices?
FDA recall records list 1 recall initiated by Abbott Vascular Devices, the most recent initiated on 21 Jul 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Abbott Vascular Devices in the registry?
The most recently registered devices listed for Abbott Vascular Devices include MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM, CATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER and STARCLOSURE SE VASCULAR CLOSURE SYSTEM.