Cleared Traditional

K020132 - CHASE CARDIOVASCULAR PATCH KIT
(FDA 510(k) Clearance)

K020132 · Chase Medical, Inc. · Cardiovascular

Feb 2002

Decision

42d

Days

Class 2

Risk

K020132 is an FDA 510(k) clearance for the CHASE CARDIOVASCULAR PATCH KIT, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on February 26, 2002, 42 days after receiving the submission on January 15, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K020132 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 2002
Decision Date	February 26, 2002
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement