Clearance Summary
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M received FDA 510(k) clearance under submission number K130873, sponsored by Vital Access. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2013-09-13.
- Submission: K130873
- Applicant / Sponsor: Vital Access
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2013-09-13
Classification & Regulation
This clearance is catalogued under FDA product code PFH and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.