510(k) K043489 ยท DQY Catheter, Percutaneous
ENPATH DEFLECTABLE CATHETER
| Applicant | Enpath Medical Incorporated, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 19, 2005 |
| Received | Dec 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2006 | Enpath Medical, Inc. Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled Terminated |
DQY | None listed |
| Sep 21, 2005 | Enpath Medical, Inc. Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tippe Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.