The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Vascupuncture Access Wire.
| Device ID | K012861 |
| 510k Number | K012861 |
| Device Name: | VASCUPUNCTURE ACCESS WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEO METRICS, INC. 15301 HIGHWAY 55 WEST Minneapolis, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Gene Champeau NEO METRICS, INC. 15301 HIGHWAY 55 WEST Minneapolis, MN 55447 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-24 |
| Decision Date | 2002-02-05 |
| Summary: | summary |