CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump— 510(k) K172305

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K172305 for CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump, Substantially Equivalent on 2017-10-12. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 2017-07-31
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Manwah, NJ, 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.