The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Mercy Retriever, Model 90070.
Device ID | K070521 |
510k Number | K070521 |
Device Name: | MODIFIED MERCY RETRIEVER, MODEL 90070 |
Classification | Catheter, Thrombus Retriever |
Applicant | CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
Contact | Kirsten Valley |
Correspondent | Kirsten Valley CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
Product Code | NRY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-23 |
Decision Date | 2007-04-24 |
Summary: | summary |