510(k) K982187 ยท DYB Introducer, Catheter
FAST-CATH INTRA-CARDIAC INTRODUCER
| Applicant | Daig Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 16, 1998 |
| Received | Jun 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi Terminated |
DYB | None listed |
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-r Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.