Cleared Traditional

VASCULAR SONO

K113196 · PAJUNK GmbH Medizintechnologie · Cardiovascular
Feb 2012
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K113196 is an FDA 510(k) clearance for the VASCULAR SONO, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on February 6, 2012, 98 days after receiving the submission on October 31, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K113196 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2011
Decision Date February 06, 2012
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340