TightRail Sub-C Rotating Dilator Sheath— 510(k) K161333

Substantially Equivalent

Spectranetics, Inc.

FDA 510(k) clearance K161333 for TightRail Sub-C Rotating Dilator Sheath, Substantially Equivalent on 2016-07-08. Applicant: Spectranetics, Inc..

Clearance details

Applicant: Spectranetics, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2016-05-12
Decision date: 2016-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

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.