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510(k) K811235

DISPOSABLE HOLDER FOR HANCOCK MITRAL by Vascor, Inc. — Product Code DTJ

K811235 is an FDA 510(k) premarket notification submitted by Vascor, Inc. for the device "DISPOSABLE HOLDER FOR HANCOCK MITRAL". The FDA issued a decision of Substantially Equivalent on May 13, 1981. The device falls under product code DTJ (Holder, Heart-Valve, Prosthesis), a Class I device regulated under 21 CFR 870.3935. Vascor, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
May 4, 1981
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 Vascor, Inc.

  • K811236 — DISPOSABLE HOLDER FOR HANCOCK AORTIC (May 13, 1981)

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)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)

FDA data resources