The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Balloon Guide Catheter, Model 90072.
| Device ID | K021899 |
| 510k Number | K021899 |
| Device Name: | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Mountain View, CA 94043 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Mountain View, CA 94043 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-07-10 |
| Summary: | summary |