Cleared Traditional

Attachable Cath Lab Hemostasis Valve

K152528 · Galt Medical Corp. · Cardiovascular

Dec 2015

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K152528 is an FDA 510(k) clearance for the Attachable Cath Lab Hemostasis Valve, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Galt Medical Corp. (Garland, US). The FDA issued a Cleared decision on December 2, 2015, 90 days after receiving the submission on September 3, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K152528 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2015
Decision Date	December 02, 2015
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290