The following data is part of a premarket notification filed by Concentric Medical with the FDA for 8f Flowgate2 Balloon Guide Catheter.
| Device ID | K153729 |
| 510k Number | K153729 |
| Device Name: | 8F FlowGate2 Balloon Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL 301 EAST EVELYN AVENUE Mountain View, CA 94041 |
| Contact | Shazia Hakim |
| Correspondent | Shazia Hakim CONCENTRIC MEDICAL 301 EAST EVELYN AVENUE Mountain View, CA 94041 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742004953 | K153729 | 000 |
| 00815742004854 | K153729 | 000 |