Venous Window Needle Guide
The Venous Window Needle Guide is a gastrointestinal and urology device used as an access accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site (buttonhole) cannulation technique, guiding needle insertion to the same location at each treatment session to maintain fistula integrity. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5540, requiring 510(k) premarket notification. It is flagged as both an implant and life-sustaining, reflecting its role in maintaining vascular access for patients dependent on hemodialysis.
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Basic Information
- Product Code
- PFH
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K130873 | VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M | Sep 13, 2013 | Substantially Equivalent | Vital Access |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.