INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION— 510(k) K940231

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K940231 for INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION, Substantially Equivalent on 1994-09-13. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1994-01-18
Decision date: 1994-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

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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.