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510(k) K881279

EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET by Baxter Healthcare Corp — Product Code DTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1988
Date Received
March 22, 1988
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

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Other clearances for product code DTI

  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K934951 — VALVE SIZER (December 10, 1993)
  • K853313 — DUROMEDICS CARDIAC VALVE SIZER SET (November 1, 1985)
  • K852612 — METRONIC MODEL F7700 HEART VALVE SIZERS (September 23, 1985)
  • K820887 — MITRAL VALVE ORIFICE SIZER (July 8, 1982)
  • K801885 — HANCOCK * OBTURATORS (September 9, 1980)