Catheter Guide Wire Kit
FDA product code OFB · Class II (moderate risk) · 21 CFR 870.1330 · Cardiovascular
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
0510(k) clearances
0PMA approvals
2recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2368-2026 Class I | Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1911-2026 Class II | ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code:…Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | Arrow International, LLC | 03/11/2026Open, Classified |