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510(k) K001915

GRAFT MARKER RING by T. Korossurgical Instruments Corp. — Product Code MAB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2001
Date Received
June 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Cardiopulmonary Bypass (Vein Marker)
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

Other clearances by T. Korossurgical Instruments Corp.

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K954016 — VIDEOSCOPE W/IRRIGATION SHEATH (January 25, 1996)
  • K953998 — DISCETOME TISSUE ASPIRATOR (December 4, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (August 6, 1993)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)
  • K931262 — REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR (August 6, 1993)
  • K931259 — ENDOSCOPIC OR THORASCOPIC FORCEPS (June 8, 1993)

Other clearances for product code MAB

  • K052642 — SUTURING WASHER (January 17, 2006)
  • K894268 — C.A.B. RING (August 17, 1989)