510(k) K061772 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
TRIACTIV FX EMBOLIC PROTECTION SYSTEM
| Applicant | Kensey Nash Corp., Exton PA, US |
| Decision | Substantially Equivalent, Jul 11, 2006 |
| Received | Jun 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061772
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2007 | Kensey Nash Corp TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the Shie Terminated |
FRO | None listed |
| May 31, 2007 | Kensey Nash Corp FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box. Terminated |
FRO | None listed |
| May 31, 2007 | Kensey Nash Corp ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.