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510(k) K970654

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) by Baxter Healthcare Corp — Product Code MSE

K970654 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)". The FDA issued a decision of Substantially Equivalent on November 12, 1997. The device falls under product code MSE (Hemodialyzer, Re-Use, Low Flux), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1997
Date Received
February 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, Low Flux
Device Class
Class II
Regulation Number
876.5820
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 MSE

  • K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (November 15, 2000)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (August 27, 1998)
  • K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (November 12, 1997)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)

FDA data resources