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510(k) K934951

VALVE SIZER by Carbomedics, Inc. — Product Code DTI

K934951 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "VALVE SIZER". The FDA issued a decision of Substantially Equivalent on December 10, 1993. The device falls under product code DTI (Sizer, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3945. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1993
Date Received
October 18, 1993
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 by Carbomedics, Inc.

  • K970375 — ANNULOFLO SYSTEM (July 25, 1997)
  • K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (February 19, 1997)
  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)
  • K960706 — VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT (April 25, 1996)
  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K955588 — VASCUTEK GRAFT SIZER SET (March 7, 1996)
  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)
  • K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (July 6, 1994)

Other clearances for product code DTI

  • K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (November 29, 1995)
  • K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (May 18, 1988)
  • 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)

FDA data resources