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510(k) K831424

THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 by Extracorporeal Medical Specialities, Inc. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
May 3, 1983
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 Extracorporeal Medical Specialities, Inc.

  • K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR (November 29, 1984)
  • K840532 — HEMOPERFUSION SYSTEM TP-400 (May 30, 1984)
  • K840262 — HANCOCK PERICARDIAL PATCH (May 30, 1984)
  • K840146 — EXP* 700 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K840057 — EXP* 500 PARALLEL PLATE DIALYZER (February 4, 1984)
  • K832547 — ULTRAFILTRATION CONTROLLER (January 3, 1984)
  • K831423 — THERAPEUTIC EXCHANGE SYSTEM (January 3, 1984)
  • K833476 — INTERSEPT 40 MICRON FILTER W/TUBING (December 27, 1983)
  • K833477 — INTERSEPT 40 MICRON FILTER (December 27, 1983)
  • K832053 — SINGLE PATIENT SYS. II MODEL DM-450 (September 29, 1983)

Other clearances for product code FJK

  • K251341 — VITAL Tubing Sets for Hemodialysis (January 16, 2026)
  • K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (October 2, 2025)
  • K243607 — Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (December 20, 2024)
  • K213992 — CombiSet Hemodialysis Blood Tubing Set (May 31, 2023)
  • K210782 — Tablo Cartridge (November 26, 2021)
  • 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)