The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Concentric Retriever, Model 90038.
Device ID | K040745 |
510k Number | K040745 |
Device Name: | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 |
Classification | Catheter, Percutaneous |
Applicant | CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
Contact | Kevin F Macdonald |
Correspondent | Kevin F Macdonald CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain 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 | 2004-03-23 |
Decision Date | 2004-08-11 |
Summary: | summary |