C.R. Bard Inc., Bard Electrophysiology Division
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What C.R. Bard Inc., Bard Electrophysiology Division makes
C.R. Bard’s Bard Electrophysiology Division manufactures software for electrophysiological (EP) recording, including the LABSYSTEM PRO EP Recording System (versions 2.6 and 3.1) for cardiac mapping and ablation procedures. The company also produces polytetrafluoroethylene (PTFE, or Teflon)-coated guide wires used in interventional cardiology for vascular access and catheter navigation.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance pathway. The products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Labsystem Pro Ep Recording System V3.1 Software Ref K101331
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Bard Ptfe (Teflon) Coated Guide Wires Ref K082094
Regimes: 510(k) Registry: 510(k)
FDA recalls
2008
- 1 Oct 2008 Z-0280-2009 Unclassified (pre-2012) Terminated Failure to insert the guidewire through the introducer needle.
Frequently asked questions
How many devices does C.R. Bard Inc., Bard Electrophysiology Division have in the registry?
The registry currently lists 3 devices for C.R. Bard Inc., Bard Electrophysiology Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list C.R. Bard Inc., Bard Electrophysiology Division's devices?
Among its 3 most recently registered devices, C.R. Bard Inc., Bard Electrophysiology Division has devices listed in FDA 510(k) (3 devices).
What risk classes do C.R. Bard Inc., Bard Electrophysiology Division's devices fall under?
Among its 3 most recently registered devices, the classes recorded for C.R. Bard Inc., Bard Electrophysiology Division's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for C.R. Bard Inc., Bard Electrophysiology Division?
FDA recall records list 1 recall initiated by C.R. Bard Inc., Bard Electrophysiology Division, the most recent initiated on 1 Oct 2008. 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 C.R. Bard Inc., Bard Electrophysiology Division in the registry?
The most recently registered devices listed for C.R. Bard Inc., Bard Electrophysiology Division include LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE, V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM and BARD PTFE (TEFLON) COATED GUIDE WIRES.