The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Occlusion Balloon Catheter.
| Device ID | K070126 |
| 510k Number | K070126 |
| Device Name: | OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2008-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354017571 | K070126 | 000 |
| 30840143901700 | K070126 | 000 |
| 30840143903667 | K070126 | 000 |
| 30840143909409 | K070126 | 000 |
| M95520060 | K070126 | 000 |