The following data is part of a premarket notification filed by Vital Access with the FDA for Vwing Vascular Needle Guide, 4mm X 07mm; Vwing Vascular Needle Guide, 6mm X 07mm; Vwing Vascular Needle Guide, 8mm X 07m.
| Device ID | K130873 |
| 510k 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 |
| Classification | Venous Window Needle Guide |
| Applicant | VITAL ACCESS 2302 S.PRESIDENTS DR SUITE C Salt Lake City, UT 84120 |
| Contact | Christopher Phillips |
| Correspondent | Christopher Phillips VITAL ACCESS 2302 S.PRESIDENTS DR SUITE C Salt Lake City, UT 84120 |
| Product Code | PFH |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2013-09-13 |
| Summary: | summary |