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510(k) K944214

BAXTER HANDLE MODEL 1150 by Baxter Edwards — Product Code DTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
August 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Heart-Valve, Prosthesis
Device Class
Class I
Regulation Number
870.3935
Review Panel
CV
Submission Type

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Other clearances for product code DTJ

  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K942736 — CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (July 6, 1994)
  • K880052 — EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR (April 1, 1988)
  • K871596 — IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) (June 15, 1987)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K813276 — IONESCU-SHILEY VALVE HOLDER & HANDLE (December 10, 1981)
  • K811236 — DISPOSABLE HOLDER FOR HANCOCK AORTIC (May 13, 1981)
  • K811235 — DISPOSABLE HOLDER FOR HANCOCK MITRAL (May 13, 1981)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)