Clearance Summary
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 received FDA 510(k) clearance under submission number K021462, sponsored by Arrow Intl., 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 2002-06-06.
- Submission: K021462
- Applicant / Sponsor: Arrow Intl., Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 2002-06-06
Classification & Regulation
This clearance is catalogued under FDA product code DSP and 21 CFR 870.3535, within the Cardiovascular review panel as a Class II device.