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510(k) K962154

CARBOMEDICS HANDLE by Carbomedics, Inc. — Product Code DTJ

K962154 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "CARBOMEDICS HANDLE". The FDA issued a decision of Substantially Equivalent on August 27, 1996. The device falls under product code DTJ (Holder, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3935. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1996
Date Received
June 4, 1996
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

Other clearances by Carbomedics, Inc.

  • K970375 — ANNULOFLO SYSTEM (July 25, 1997)
  • K964665 — VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (February 19, 1997)
  • 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)
  • K934951 — VALVE SIZER (December 10, 1993)

Other clearances for product code DTJ

  • K960169 — CARBOMEDICS VALVE TESTER (April 15, 1996)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
  • 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)

FDA data resources