The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Vascupuncture Picc Guidewire With Hydro-silk Coating.
| Device ID | K040786 |
| 510k Number | K040786 |
| Device Name: | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING |
| 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 | 2004-03-29 |
| Decision Date | 2004-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40888277751973 | K040786 | 000 |