510(k) K130873
- Device
- VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
- Applicant
- VITAL ACCESS
- 510(k) number
- K130873
- Product code
- PFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-09-13
- Date received
- 2013-03-29
- Regulation
- 876.5540
- Classification name
- Venous Window Needle Guide
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER PHILLIPS
- Address
- 2302 S.Presidents Dr. Suite C Salt Lake City UT US 84120 84120
FDA Registration Numbers#
- 3009973699
- 3009998573
Source Documents#
Legacy Summary#
summary
FDA Review#
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