ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
FDA 510(k) clearance K082746 · decided 2009-01-12
Clearance details
- K-number
- K082746
- Device name
- ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
- Applicant
- Insightra Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-19
- Decision date
- 2009-01-12
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Nu recall (Z-2298-2025) | Insightra Medical Inc | 2025-08-13 |