510(k) K970392 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Apr 24, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2021 | Cordis Corporation Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. Terminated |
DRE | None listed |
| Mar 15, 2016 | Cordis Corporation CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM
The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intra Terminated |
DRE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.