TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath— 510(k) K142546

Substantially Equivalent

Spectranetics, Inc.

FDA 510(k) clearance K142546 for TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath, Substantially Equivalent on 2014-09-25. Applicant: Spectranetics, Inc..

Clearance details

Applicant: Spectranetics, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2014-09-10
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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.