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510(k) K864155

MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS by American Edwards Laboratories — Product Code DTJ

K864155 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on November 20, 1986. The device falls under product code DTJ (Holder, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3935. American Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1986
Date Received
October 23, 1986
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 American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (September 30, 1987)
  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)
  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)

Other clearances for product code DTJ

  • K962154 — CARBOMEDICS HANDLE (August 27, 1996)
  • 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)
  • 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