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510(k) K853313

DUROMEDICS CARDIAC VALVE SIZER SET by Hemex Scientific, Inc. — Product Code DTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
August 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sizer, Heart-Valve, Prosthesis
Device Class
Class I
Regulation Number
870.3945
Review Panel
CV
Submission Type

Other clearances for product code DTI

  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K934951 — VALVE SIZER (December 10, 1993)
  • K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (May 18, 1988)
  • K852612 — METRONIC MODEL F7700 HEART VALVE SIZERS (September 23, 1985)
  • K820887 — MITRAL VALVE ORIFICE SIZER (July 8, 1982)
  • K801885 — HANCOCK * OBTURATORS (September 9, 1980)