The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Hd Guide Catheter.
| Device ID | K133177 |
| 510k Number | K133177 |
| Device Name: | MODIFIED HD GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL, INC. 301 EAST EVELYN AVENUE Mountain View, CA 94041 |
| Contact | Rhoda Santos |
| Correspondent | Rhoda Santos CONCENTRIC MEDICAL, INC. 301 EAST EVELYN AVENUE Mountain View, CA 94041 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327313987 | K133177 | 000 |
| 07613327313963 | K133177 | 000 |
| 07613327313949 | K133177 | 000 |
| 07613327313932 | K133177 | 000 |
| 07613327313925 | K133177 | 000 |
| 07613327313918 | K133177 | 000 |
| 07613327313901 | K133177 | 000 |
| 07613327313895 | K133177 | 000 |
| 07613327313888 | K133177 | 000 |