Home / 510(k) Clearances / K001915

510(k) K001915

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

K001915 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "GRAFT MARKER RING". The FDA issued a decision of Substantially Equivalent on April 27, 2001. The device falls under product code MAB (Marker, Cardiopulmonary Bypass (Vein Marker)), a Class II device regulated under 21 CFR 870.3450. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.

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)
  • K954052 — ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES (November 6, 1995)
  • K954014 — PERCUTANEOUS DISCECTOMY CANNULA SYSTEM (November 6, 1995)
  • K935529 — CERVICAL SELF-RETAINING RETRACTOR (March 22, 1994)
  • K926583 — REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR (August 6, 1993)
  • K926585 — THOROCOSCOPY SELF-RETAINING RETRACTOR (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)

FDA data resources