510(k) K902327 ยท DXE Catheter, Embolectomy
EMBOLECTOMY CATHETER
| Applicant | Clincal Instruments Corp., Dudley MA, US |
| Decision | Substantially Equivalent, Feb 25, 1991 |
| Received | May 24, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | Arrow International Inc Walrus Arterial Embolectomy Catheter
The arterial embolectomy catheter is intended for use in removing arterial emboli. Terminated |
DXE | None listed |
| Jun 25, 2009 | Arrow International Inc Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605.
The arterial embolectomy c Terminated |
DXE | None listed |
| Jun 25, 2009 | Arrow International Inc Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605.
The arterial embolectomy c Terminated |
DXE | None listed |
| Jun 25, 2009 | Arrow International Inc Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605.
The arterial embolectomy c Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.