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510(k) K960923

CARBOMEDICS MITRAL ROTATOR by Carbomedics, Inc. — Product Code MOP

K960923 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "CARBOMEDICS MITRAL ROTATOR". The FDA issued a decision of Substantially Equivalent on April 29, 1996. The device falls under product code MOP (Rotator, Prosthetic Heart Valve), 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
April 29, 1996
Date Received
March 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rotator, Prosthetic Heart Valve
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)
  • K962154 — CARBOMEDICS HANDLE (August 27, 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 MOP

  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)
  • K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (August 4, 1998)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)

FDA data resources