510(k) K042040 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
TRIACTIV SYSTEM
| Applicant | Kensey Nash Corp., Exton PA, US |
| Decision | Substantially Equivalent, Mar 23, 2005 |
| Received | Jul 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | None listed |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | None listed |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes. Terminated |
NFA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.