510(k) K964518 ยท DYB Introducer, Catheter
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
| Applicant | Daig Corp., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 14, 1997 |
| Received | Oct 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964518
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2012 | St Jude Medical Inc Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343
Indicated for introducing various cardiovas Terminated |
DYB | None listed |
| Mar 1, 2007 | St. Jude Medical / Daig Division FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. 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. 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.