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 |