Cleared Traditional

GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE

K122301 · Vascular Solutions Zerusa , Ltd. · Cardiovascular

Sep 2012

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K122301 is an FDA 510(k) clearance for the GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Vascular Solutions Zerusa , Ltd. (Minneapolis, US). The FDA issued a Cleared decision on September 7, 2012, 37 days after receiving the submission on August 1, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K122301 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2012
Decision Date	September 07, 2012
Days to Decision	37 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