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510(k) K852749

RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT by Mesa Medical, Inc. — Product Code FKQ

K852749 is an FDA 510(k) premarket notification submitted by Mesa Medical, Inc. for the device "RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT". The FDA issued a decision of Substantially Equivalent on September 10, 1985. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Mesa Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1985
Date Received
June 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Mesa Medical, Inc.

  • K925210 — 90DX MULTITEST METER, MODIFICATION (January 25, 1994)
  • K882032 — MODEL 90DX MULTITEST METER (August 11, 1988)
  • K870811 — MODEL 102 PH METER (March 24, 1987)
  • K843520 — WAREXIN RECOMMENDED ALTERNATIVE DIALYZ (October 4, 1984)
  • K834447 — ECHO MM1000 (March 23, 1984)
  • K821383 — ECHO, MODEL MM-1000 (June 23, 1982)

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

FDA data resources