510(k) K040260 ยท MSD Catheter, Hemodialysis, Implanted
INTEGRAL HEMODIALYSIS CATHETER
| Applicant | Arrow Int'L., Reading PA, US |
| Decision | Substantially Equivalent, Mar 5, 2004 |
| Received | Feb 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CS-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CS-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CS-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville R Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville R Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CSD-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CSD-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Terminated |
MSD | None listed |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.