DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS— 510(k) K904414

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K904414 for DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS, Substantially Equivalent on 1990-10-22. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1990-08-20
Decision date: 1990-10-22
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.