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510(k) K840687

KIDNEY TRANSPLANT CATHETER by Warne Surgical Products, Ltd. — Product Code KDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1984
Date Received
February 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)
  • K840703 — SECURE W/30MM DIAM, SHEATH & ADHESIVE (March 22, 1984)

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