Panels › Cardiovascular › Product code OFK · Class 2
Percutaneous Atrial Catheter Kit
Regulation 870.1250
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 OFK
| 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 1-3/4IN/AK-04020-SPC;
RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW;
ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM5;
CATH SL 20 GA X 5 CM HYDROPHILIC/ASK-00520-JH;
CAT Open, Classified |
OFK | None listed |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B;
SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C;
SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B Open, Classified |
OFK | None listed |
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