VESSEL DILATOR— 510(k) K904476

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K904476 for VESSEL DILATOR, Substantially Equivalent on 1990-12-10. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1990-10-01
Decision date: 1990-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.