Clearance Summary
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 received FDA 510(k) clearance under submission number K032568, sponsored by Med Textile, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-04-29.
- Submission: K032568
- Applicant / Sponsor: Med Textile, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2004-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.