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510(k) K822386

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA by Hospal Medical Corp. — Product Code FII

K822386 is an FDA 510(k) premarket notification submitted by Hospal Medical Corp. for the device "COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code FII (System, Dialysate Delivery, Sealed), a Class II device regulated under 21 CFR 876.5860. Hospal Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
August 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sealed
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Hospal Medical Corp.

  • K893742 — FILTRAL TM 20 HEMODIALYZER/FILTER (July 24, 1989)
  • K884365 — MULTIFLOW(TM) 60 KIT (December 8, 1988)
  • K884326 — FILTRAL TM 8 HEMODIALYZER (December 5, 1988)
  • K883307 — CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT (October 12, 1988)
  • K872767 — FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER (December 29, 1987)
  • K871218 — MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT (April 30, 1987)
  • K863961 — HOSPAL BIOSPAL 1800S (December 17, 1986)
  • K863592 — DISSCAP 80E, 110E, 140E, 160E (September 25, 1986)
  • K861156 — HOSPAL DIALYSATE FOR CAVHD (September 23, 1986)
  • K861230 — MONITRAL S (April 25, 1986)

Other clearances for product code FII

  • K030470 — NXSTAGE SYSTEM ONE (July 7, 2003)
  • K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10 (August 24, 1988)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K862716 — HEMOFILTRATION SYSTEM 10 (September 9, 1986)

FDA data resources