The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for 6f Z4 Guide Catheter.
Device ID | K042489 |
510k Number | K042489 |
Device Name: | 6F Z4 GUIDE CATHETER |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Contact | Fred L Boucher |
Correspondent | Fred L Boucher MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-14 |
Decision Date | 2004-12-13 |
Summary: | summary |