THE PILOT SCIMED TORQUE DEVICE— 510(k) K896108

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K896108 for THE PILOT SCIMED TORQUE DEVICE, Substantially Equivalent on 1990-01-09. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code LOX
Advisory panel: Cardiovascular
Date received: 1989-10-23
Decision date: 1990-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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.