MEDI-TECH DILATATION CATHETERS ULTRA THIN II— 510(k) K897106

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K897106 for MEDI-TECH DILATATION CATHETERS ULTRA THIN II, Substantially Equivalent on 1990-10-16. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1989-12-21
Decision date: 1990-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.