The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Zuma Guide Catheters.
Device ID | K000677 |
510k Number | K000677 |
Device Name: | ZUMA GUIDE CATHETERS |
Classification | Catheter, Percutaneous |
Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
Contact | Fred L Boucher |
Correspondent | Fred L Boucher MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-29 |
Decision Date | 2000-03-29 |