Cleared Traditional

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL

K914523 · Catheter Research C/O Burditt, Bowles & Radzius · Cardiovascular

Jan 1992

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K914523 is an FDA 510(k) clearance for the CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL, a Clip, Vascular (Class II — Special Controls, product code DSS), submitted by Catheter Research C/O Burditt, Bowles & Radzius (Indianapolis, US). The FDA issued a Cleared decision on January 10, 1992, 92 days after receiving the submission on October 10, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3250.

Submission Details

510(k) Number	K914523 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 1991
Decision Date	January 10, 1992
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement