Clearance Summary
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT received FDA 510(k) clearance under submission number K021984, sponsored by Inceptio Medical Technologies, LC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-07-02.
- Submission: K021984
- Applicant / Sponsor: Inceptio Medical Technologies, LC
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2002-07-02
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.