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510(k) K935184

REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING by St. Jude Medical, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
October 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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  • K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (December 17, 2004)

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