Panels › Cardiovascular › Product code OFC · Class 2
Catheter Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (1 all time)
3recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in OFC
| Company | 510(k)s | Recalls |
|---|---|---|
| ARROW INTERNATIONAL, LLC | 0 | 3 |
| Prytime Medical Devices, Inc. | 0 | 1 |
| Spectranetics Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH;
PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4;
PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1;
PSI KIT: 9 FR X 4 1/8 IN (10 CM Open, Classified |
OFC | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC Arrowg+ard Blue MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC
UDI code: (01)10801902218930(17)270630(11)251211(10)33F25M0671
The MAC Multi-Lumen Centr Open, Classified |
OFC | None listed |
| Apr 22, 2026 | ARROW INTERNATIONAL, LLC MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2
UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670
The MAC Multi-Lumen Central Venous Access Open, Classified |
OFC | None listed |
| Dec 14, 2020 | Prytime Medical Devices, Inc. PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C,
Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, Terminated |
OFC | None listed |
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