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510(k) K790022

DISPOSABLE HOLDER FOR BIOPROSTHESIS by Edwards Laboratories — Product Code DTJ

K790022 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "DISPOSABLE HOLDER FOR BIOPROSTHESIS". The FDA issued a decision of Substantially Equivalent on January 15, 1979. The device falls under product code DTJ (Holder, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3935. Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1979
Date Received
January 3, 1979
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 Edwards Laboratories

  • K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (July 28, 1980)
  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (March 17, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A (February 26, 1979)
  • K781535 — AC ADAPTER:MODELS 9525,9526,9527 (September 15, 1978)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K771046 — VENA CAVA UMBRELLA FILTER, MODEL 7321 (June 22, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

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)
  • 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)

FDA data resources