The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Hydrophilic Guidewire, Models 90011, 90012.
| Device ID | K003084 |
| 510k Number | K003084 |
| Device Name: | CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 |
| Classification | Wire, Guide, Catheter |
| Applicant | CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
| Contact | Linda Bradley |
| Correspondent | Linda Bradley CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2001-05-16 |