The following data is part of a premarket notification filed by Ultrasonix Medical Corpation with the FDA for Sonixgps Vascular Access Needle Kit.
| Device ID | K120349 |
| 510k Number | K120349 |
| Device Name: | SONIXGPS VASCULAR ACCESS NEEDLE KIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ULTRASONIX MEDICAL CORPATION 130-4311 VIKING WAY Richond, Bc, CA V6v 2k9 |
| Contact | Chas Yu |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-04-09 |
| Summary: | summary |