510(k) K160018 ยท DQX Wire, Guide, Catheter
Arrow Quickflash Arterial Catheterization Device
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Jun 13, 2016 |
| Received | Jan 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160018
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A;
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018 Open, Classified |
DQX | None listed |
| Mar 21, 2024 | ARROW INTERNATIONAL Inc. ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:
a) REF AK-04220;
b) REF ASK-04220-FMH1;
c) REF ASK-04220-HHC;
d) REF ASK-04220-KSP;
e) REF ASK-04220-PSU;
f) Open, Classified |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.