VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
FDA 510(k) clearance K130873 · decided 2013-09-13
Clearance details
- K-number
- K130873
- Device name
- VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
- Applicant
- Vital Access
- Decision
- Substantially Equivalent
- Date received
- 2013-03-29
- Decision date
- 2013-09-13
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- PFH
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.