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510(k) K921597

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 by Haemotronic, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1995
Date Received
April 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Haemotronic, Inc.

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  • K921595 — Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 (December 24, 1992)
  • K921594 — HAEMOTROL MODEL #HT-SB/6 BURETTE SET (December 24, 1992)
  • K913361 — DRAIN/PRIMING/RECIRCULATION BAG (March 30, 1992)

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  • K202796 — SANSIN Tubing Sets for Hemodialysis (September 6, 2021)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K171952 — Dimesol Tubing Sets for Hemodialysis (March 30, 2018)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)
  • K150304 — Oxyless Blood Tubing Set (February 24, 2016)