MANIFOLD— 510(k) K811004

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K811004 for MANIFOLD, Substantially Equivalent on 1981-05-08. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 1981-04-13
Decision date: 1981-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.