510(k) K022093

CHASE CARDIOVASCULAR PATCH KIT by Chase Medical, Inc. — Product Code DXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2002
Date Received
June 27, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type