510(k) K172305 ยท DSP System, Balloon, Intra-Aortic And Control
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
| Applicant | Datascope Corp., Manwah NJ, US |
| Decision | Substantially Equivalent, Oct 12, 2017 |
| Received | Jul 31, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172305
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2026 | Datascope Corp. CS100 IABP. Software Version CS100 IABP Q.01. Open, Classified |
DSP | None listed |
| Mar 3, 2026 | Datascope Corp. CS300 IABP. Software Version CS300 IABP C.01. Open, Classified |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.