510(k) K984022 ยท MPB Catheter, Hemodialysis, Non-Implanted
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 18, 1999 |
| Received | Nov 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F;
HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122;
HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC;
HEMODIALYSIS KIT 2L: 14 FR X 2 Open, Classified |
MPB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.