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510(k) K013939

JOSTRA FLOWPROBE FP-32E by Jostra AG — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2001
Date Received
November 29, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

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  • K022022 — JOSTRA VENT CATHETERS, MODELS LV & HKV (September 11, 2002)
  • K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (April 24, 2002)
  • K014303 — JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (March 26, 2002)
  • K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (February 11, 2002)
  • K012774 — JOSTRA ARTERIAL PERFUSION CANNULAE (November 16, 2001)

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