INTRODUCER SHEATH AND DILATOR— 510(k) K971165

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K971165 for INTRODUCER SHEATH AND DILATOR, Substantially Equivalent on 1997-07-23. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LDF
Advisory panel: Cardiovascular
Date received: 1997-03-31
Decision date: 1997-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.