Clearance Summary
Cook-Swartz Doppler Flow Probe received FDA 510(k) clearance under submission number K171272, sponsored by Cook Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-07-17.
- Submission: K171272
- Applicant / Sponsor: Cook Incorporated
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2018-07-17
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.