EXPANDING VASCULAR SHEATH— 510(k) K070865

Substantially Equivalent

Applied Medical

FDA 510(k) clearance K070865 for EXPANDING VASCULAR SHEATH, Substantially Equivalent on 2007-10-23. Applicant: Applied Medical.

Clearance details

Applicant: Applied Medical
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2007-03-29
Decision date: 2007-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

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.