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510(k) K981253

ULTRACON ULTRAFILTRATOR by Interpore Intl. — Product Code FJI

K981253 is an FDA 510(k) premarket notification submitted by Interpore Intl. for the device "ULTRACON ULTRAFILTRATOR". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Interpore Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
April 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Interpore Intl.

  • K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5R (September 25, 1998)
  • K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (October 30, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K960945 — IMZ MEMBRANE TACK SYSTEM (May 24, 1996)
  • K960371 — INTERPORE THREADED IMPLANT (March 8, 1996)
  • K955492 — INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (January 30, 1996)
  • K952167 — IMZ BONE TACK SYSTEM (November 21, 1995)
  • K950165 — INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 100 (March 28, 1995)
  • K922872 — INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (July 25, 1994)
  • K922732 — INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER (February 10, 1994)

Other clearances for product code FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)

FDA data resources