The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Vascupuncture Picc Guidewire.
| Device ID | K070150 |
| 510k Number | K070150 |
| Device Name: | VASCUPUNCTURE PICC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEOMETRICS, INC. 14800 28TH AVE. N. SUITE 150 Plymouth, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Gene Champeau NEOMETRICS, INC. 14800 28TH AVE. N. 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 | 2007-01-16 |
| Decision Date | 2007-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902156731 | K070150 | 000 |
| 20801902156727 | K070150 | 000 |
| 20801902156710 | K070150 | 000 |
| 20801902198451 | K070150 | 000 |