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 |