Cleared Special

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)

K223472 · Spectranetics, Inc. · Cardiovascular

Dec 2022

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K223472 is an FDA 510(k) clearance for the TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013), 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 December 15, 2022, 28 days after receiving the submission on November 17, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number	K223472 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2022
Decision Date	December 15, 2022
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF