Cleared Traditional

ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT

K982365 · Geister Medizin Technik GmbH · Cardiovascular
Apr 1999
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K982365 is an FDA 510(k) clearance for the ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Geister Medizin Technik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on April 8, 1999, 275 days after receiving the submission on July 7, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K982365 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1998
Decision Date April 08, 1999
Days to Decision 275 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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