Cleared Traditional

K182660 - GaltTWS (FDA 510(k) Clearance)

K182660 · Galt Medical Corp. · Cardiovascular device
May 2019
Decision
247d
Days
Class 2
Risk

K182660 is an FDA 510(k) clearance for the GaltTWS. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).

Submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on May 30, 2019, 247 days after receiving the submission on September 25, 2018.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.

Submission Details

510(k) Number K182660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2018
Decision Date May 30, 2019
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRB - Stylet, Catheter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1380