COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67— 510(k) K964821

Substantially Equivalent

Ventrex, Inc.

FDA 510(k) clearance K964821 for COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67, Substantially Equivalent on 1997-07-16. Applicant: Ventrex, Inc..

Clearance details

Applicant: Ventrex, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1996-12-02
Decision date: 1997-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.