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510(k) K823768

CLIRANS TE08 HOLLOW FIBER DIALYZER by Terumo Medical Corp. — Product Code HRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
December 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

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  • K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER (April 15, 2009)
  • K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) (February 6, 2009)
  • K082847 — PINNACLE ROII INTRODUCER SHEATH (October 29, 2008)
  • K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER (September 26, 2008)
  • K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER (September 24, 2008)

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  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K012821 — D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (October 22, 2001)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)