TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath— 510(k) K150360

Substantially Equivalent

Spectranetics, Inc.

FDA 510(k) clearance K150360 for TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath, Substantially Equivalent on 2015-03-04. Applicant: Spectranetics, Inc..

Clearance details

Applicant: Spectranetics, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2015-02-12
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Special
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.