ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20— 510(k) K082746

Substantially Equivalent

Insightra Medical, Inc.

FDA 510(k) clearance K082746 for ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20, Substantially Equivalent on 2009-01-12. Applicant: Insightra Medical, Inc..

Clearance details

Applicant: Insightra Medical, Inc.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 2008-09-19
Decision date: 2009-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.