Clearance Summary
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX received FDA 510(k) clearance under submission number K022257, sponsored by Vomed Volzer Medizintechnik GmbH & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-10-04.
- Submission: K022257
- Applicant / Sponsor: Vomed Volzer Medizintechnik GmbH & Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 2002-10-04
Classification & Regulation
This clearance is catalogued under FDA product code DRC and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.