CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)— 510(k) K964989

Substantially Equivalent

Critical Device Corp.

FDA 510(k) clearance K964989 for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5), Substantially Equivalent on 1997-04-02. Applicant: Critical Device Corp..

Clearance details

Applicant: Critical Device Corp.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1996-12-13
Decision date: 1997-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.