510(k) K791129 ยท DYB Introducer, Catheter
PERMANENT LEAD INTRADUCER
| Applicant | Daig Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 17, 1979 |
| Received | Jun 14, 1979 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K791129
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2009 | St. Jude Medical St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2 Terminated |
DQX | None listed |
| Sep 18, 2009 | St. Jude Medical St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-21 Terminated |
DQX | None listed |
| Aug 17, 2009 | St. Jude Medical SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN Terminated |
DQX | None listed |
| Aug 17, 2009 | St. Jude Medical SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.