K212784

Substantially Equivalent

TightRail Guardian Motorized Dilator Sheath

Applicant: Spectranetics, Inc.
Product code: DRE
Advisory panel: Cardiovascular
Date received: 2021-09-01
Decision date: 2022-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

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.