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510(k) K973477

BIOSENSORS EMBOLECTOMY CATHETER by Sunscope Intl., Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
September 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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  • K981747 — BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX (August 20, 1998)
  • K981745 — BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (July 17, 1998)
  • K911710 — HEPARIN COATED THERMODILUTION CATH & ACCESSORIES (October 23, 1991)
  • K912172 — SAFEWEDGE(TM) RELIEF VALVE DEVICE (September 27, 1991)

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