PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT— 510(k) K861677

Clearance details

Applicant

American Pharmaseal Div. Ahsc

Product code

Code CAC

Device class

Class 2

Regulation

21 CFR 868.5830

Advisory panel

Anesthesiology

Date received

1986-05-01

Decision date

1986-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

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Death

11

Malfunction

477

Total

488

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 →