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510(k) K964021

INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) by Baxter Edwards — Product Code HCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1997
Date Received
October 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Neurovascular Embolization
Device Class
Class II
Regulation Number
882.5950
Review Panel
NE
Submission Type

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  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
  • K944858 — BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS (January 5, 1995)
  • K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (May 24, 1994)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

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