510(k) K010399 ยท MSD Catheter, Hemodialysis, Implanted
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
| Applicant | Diatek, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Aug 14, 2001 |
| Received | Feb 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Arrow International Inc Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, Terminated |
MSD | None listed |
| Nov 1, 2003 | Arrow International Inc Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm Terminated |
KZH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.