MODEL DA-53 PRESSURE GUAGE ISOLATOR— 510(k) K761325

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K761325 for MODEL DA-53 PRESSURE GUAGE ISOLATOR, Substantially Equivalent on 1977-01-06. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1976-12-27
Decision date: 1977-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.