EVT EXPANDABLE SHEATH— 510(k) K970470

Substantially Equivalent

Guidant Cardiac and Vascular Surgery

FDA 510(k) clearance K970470 for EVT EXPANDABLE SHEATH, Substantially Equivalent on 1997-07-31. Applicant: Guidant Cardiac and Vascular Surgery.

Clearance details

Applicant: Guidant Cardiac and Vascular Surgery
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1997-02-07
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.