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510(k) K974648

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR by Sulzer Carbomedics, Inc. — Product Code MOP

K974648 is an FDA 510(k) premarket notification submitted by Sulzer Carbomedics, Inc. for the device "SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR". The FDA issued a decision of Substantially Equivalent on August 4, 1998. The device falls under product code MOP (Rotator, Prosthetic Heart Valve), a Class I device regulated under 21 CFR 870.3935. Sulzer Carbomedics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1998
Date Received
December 12, 1997
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 Sulzer Carbomedics, Inc.

  • K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 (December 17, 2002)
  • K013022 — SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (June 13, 2002)
  • K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR700 (April 23, 2002)
  • K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (January 25, 2001)
  • K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM (December 29, 1999)
  • K992056 — ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 (October 12, 1999)
  • K972201 — PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (April 14, 1998)

Other clearances for product code MOP

  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)

FDA data resources