The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Retriever, Model 90030.
Device ID | K003410 |
510k Number | K003410 |
Device Name: | CONCENTRIC RETRIEVER, MODEL 90030 |
Classification | Catheter, Percutaneous |
Applicant | CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
Contact | Sam Lazzara |
Correspondent | Sam Lazzara CONCENTRIC MEDICAL, INC. 2585 LEGHORN ST. Moutian View, CA 94043 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-02 |
Decision Date | 2001-05-22 |