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510(k) K970663

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) by Baxter Healthcare Corp — Product Code MSF

K970663 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)". The FDA issued a decision of Substantially Equivalent on January 11, 1998. The device falls under product code MSF (Hemodialyzer, Re-Use, High Flux), a Class II device regulated under 21 CFR 876.5860. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1998
Date Received
February 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, High Flux
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

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  • K163530 — PrisMax Control Unit (May 3, 2017)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code MSF

  • K023615 — GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (May 6, 2003)
  • K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (October 26, 2000)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970681 — ALTRA NOVA 200 HEMODIALYZER (July 23, 1998)
  • K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (March 11, 1998)
  • K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (March 11, 1998)
  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)

FDA data resources