The following data is part of a premarket notification filed by Insightra Medical, Inc. with the FDA for Ultra Iabp Catheter Kit, Models Imu7f-40, Imu7f-35, Imu7f-30, Imu7f-25, Imu7f-20.
| Device ID | K082746 |
| 510k Number | K082746 |
| Device Name: | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | INSIGHTRA MEDICAL, INC. 15560-C ROCKFIELD BLVD. Irvine, CA 92618 |
| Contact | Tom Colonna |
| Correspondent | Tom Colonna INSIGHTRA MEDICAL, INC. 15560-C ROCKFIELD BLVD. Irvine, CA 92618 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2009-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00837654070956 | K082746 | 000 |
| 00837654076415 | K082746 | 000 |
| 00837654076439 | K082746 | 000 |