510(k) K991431 ยท MPB Catheter, Hemodialysis, Non-Implanted
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 26, 1999 |
| Received | Apr 26, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Arrow International Inc Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions Terminated |
MPB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.