Clearance Summary
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. received FDA 510(k) clearance under submission number K171146, sponsored by Arrow International, Inc. (Subsidiary of Telelflex Inc.). The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-06-23.
- Submission: K171146
- Applicant / Sponsor: Arrow International, Inc. (Subsidiary of Telelflex Inc.)
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2017-06-23
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.