510(k) K892530 ยท DYG Catheter, Flow Directed
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Sep 26, 1989 |
| Received | Apr 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2019 | Arrow International Inc Arrow Berman Angiographic Catheter 50cc
Item Number: AI-07130 Terminated |
DYG | None listed |
| Nov 15, 2019 | Arrow International Inc Arrow Berman Angiographic Catheter 60cm
Item Number: AI-07130-J Terminated |
DYG | None listed |
| Apr 4, 2013 | Arrow International Inc Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter.
The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheteriz Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.