Panels › Cardiovascular › Product code OFB · Class 2
Catheter Guide Wire Kit
Regulation 870.1330
0510(k)s in 12 months (0 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in OFB
| Company | 510(k)s | Recalls |
|---|---|---|
| ARROW INTERNATIONAL, LLC | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1;
RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A;
ARTERIAL LINE KIT/AK-04510-S;
ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC;
ARTERIAL LINE Open, Classified |
OFB | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC ARROW RADIAL ARTERY CATHETERIZATION KIT
REF ASK-04220-UCL1
UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J0352
REF ASK-04020-EUH2
UDI code: (01)10801902213379(17)270731(11)251218(10)33F25 Open, Classified |
OFB | None listed |
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