510(k) K880860

CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 by Dlp, Inc. — Product Code DQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Occluder, Catheter Tip
Device Class
Class II
Regulation Number
870.1370
Review Panel
CV
Submission Type