510(k) K130873
K130873 is an FDA 510(k) premarket notification submitted by Vital Access for the device "VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M". The FDA issued a decision of Substantially Equivalent on September 13, 2013. The device falls under product code PFH (Venous Window Needle Guide), a Class II device regulated under 21 CFR 876.5540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2013
- Date Received
- March 29, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Venous Window Needle Guide
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.