Cleared Traditional

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

K030788 · Geister Medizin Technik GmbH · Cardiovascular
Jul 2003
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K030788 is an FDA 510(k) clearance for the KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS, a Dilator, Vessel, Surgical (Class II — Special Controls, product code DWP), submitted by Geister Medizin Technik GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on July 12, 2003, 122 days after receiving the submission on March 12, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4475.

Submission Details

510(k) Number K030788 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2003
Decision Date July 12, 2003
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DWP — Dilator, Vessel, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4475

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