PREMERE DELIVERY SHEATH, MODEL PDS— 510(k) K043084

Substantially Equivalent

Velocimed, Inc.

FDA 510(k) clearance K043084 for PREMERE DELIVERY SHEATH, MODEL PDS, Substantially Equivalent on 2005-05-02. Applicant: Velocimed, Inc..

Clearance details

Applicant: Velocimed, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2004-11-08
Decision date: 2005-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.