AUTOTRANSFUSION DEVICE— 510(k) K892819

Name: FDA 510(k) clearance K892819
Creator: U.S. Food and Drug Administration
Published: 1989-05-22

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K892819 for AUTOTRANSFUSION DEVICE, Substantially Equivalent on 1989-05-22. Applicant: Impra, Inc.. Device class: 2.

Clearance details

Applicant: Impra, Inc.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1989-04-17
Decision date: 1989-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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K991027 — BI-DIRECTIONAL TUNNELER1999-04-22
K983769 — DISTAFLO BYPASS GRAFT1998-12-15
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Adverse events under product code CAC

product code CAC

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.