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510(k) K951368

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

K951368 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "CARBOMEDICS EXENDED MITRAL ROTATOR". The FDA issued a decision of Substantially Equivalent on June 20, 1995. 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
June 20, 1995
Date Received
March 27, 1995
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)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 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)
  • 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)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)

FDA data resources