The following data is part of a premarket notification filed by Micro Interventional Systems, Inc. with the FDA for The Omniguide Guiding Catheter With Balloon.
| Device ID | K945963 |
| 510k Number | K945963 |
| Device Name: | THE OMNIGUIDE GUIDING CATHETER WITH BALLOON |
| Classification | Occluder, Catheter Tip |
| Applicant | MICRO INTERVENTIONAL SYSTEMS, INC. 680 WEST MAUDE AVE. SUITE TWO Sunnyvale, CA 94086 |
| Contact | Maria Carrillo |
| Correspondent | Maria Carrillo MICRO INTERVENTIONAL SYSTEMS, INC. 680 WEST MAUDE AVE. SUITE TWO Sunnyvale, CA 94086 |
| Product Code | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-07 |
| Decision Date | 1995-02-08 |