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510(k) K003551

VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201 by Jostra AG — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2001
Date Received
November 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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  • K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
  • K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
  • K013939 — JOSTRA FLOWPROBE FP-32E (December 14, 2001)

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