Cleared Traditional

K142546 - TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
(FDA 510(k) Clearance)

K142546 · Spectranetics, Inc. · Cardiovascular

Sep 2014

Decision

15d

Days

Class 2

Risk

K142546 is an FDA 510(k) clearance for the TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath. This device is classified as a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE).

Submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on September 25, 2014, 15 days after receiving the submission on September 10, 2014.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number	K142546 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2014
Decision Date	September 25, 2014
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF