510(k) K882981

PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP by Pioneering Technologies, Inc. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1988
Date Received
July 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type