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510(k) K980016

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code MOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1998
Date Received
January 2, 1998
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 Genzyme Surgical Product (Genzyme Biosurgery)

  • K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (November 13, 2000)
  • K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGIC (June 12, 2000)
  • K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (September 3, 1999)
  • K991416 — ENDOSCOPIC CAMERA (July 20, 1999)
  • K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 22, 1999)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (December 18, 1998)
  • K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTURE (July 7, 1998)

Other clearances for product code MOP

  • K974648 — SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (August 4, 1998)
  • K960923 — CARBOMEDICS MITRAL ROTATOR (April 29, 1996)
  • K951368 — CARBOMEDICS EXENDED MITRAL ROTATOR (June 20, 1995)