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510(k) K912172

SAFEWEDGE(TM) RELIEF VALVE DEVICE by Sunscope Intl., Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type

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  • K981745 — BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (July 17, 1998)
  • K911710 — HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (October 23, 1991)

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  • K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. (February 25, 1991)
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  • K900317 — PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER (June 22, 1990)