510(k) K082746 ยท DSP System, Balloon, Intra-Aortic And Control
ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20
| Applicant | Insightra Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 12, 2009 |
| Received | Sep 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082746
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | Insightra Medical Inc Brand Name: Ultra IABP Catheter Kit
Product Name: Ultra IABP Catheter Kit
Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20
Software Version: Not applicable
Product Descriptio Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.