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 |