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510(k) K944858

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS by Baxter Edwards — Product Code DSY

Clearance Details

Decision
ST ()
Decision Date
January 5, 1995
Date Received
October 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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  • K965137 — FOGARTY VALVULOTOME MODEL 700091 (June 4, 1997)
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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)
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  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

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