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510(k) K970661

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) by Baxter Healthcare Corp — Product Code MSE

K970661 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)". 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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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)
  • K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (November 12, 1997)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)

FDA data resources