The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Modification To Vascupuncture Picc Guidewire.
| Device ID | K043398 |
| 510k Number | K043398 |
| Device Name: | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Gene Champeau NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth, MN 55447 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-03-01 |
| Summary: | summary |