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510(k) K884154

TRANSLUMINAL ENDARTERECTOMY DEVICE by Thomas J. Fogarty, M.D. — Product Code LIF

K884154 is an FDA 510(k) premarket notification submitted by Thomas J. Fogarty, M.D. for the device "TRANSLUMINAL ENDARTERECTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code LIF (Dialyzer Reprocessing System), a Class II device regulated under 21 CFR 876.5820. Thomas J. Fogarty, M.D. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1988
Date Received
October 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer Reprocessing System
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Thomas J. Fogarty, M.D.

  • K902453 — OSCILLOMETRIC PULSE DETECTION DEVICE (August 23, 1990)
  • K831809 — FOGARTY OCCLUDER PAD (August 27, 1984)
  • K841310 — GASTROINTESTINAL DILATOR (July 31, 1984)
  • K834451 — COAXIAL BALLOON GASTROESOPHAGEAL DILA (February 4, 1984)
  • K831384 — COAXIAL BALLOON URETHRAL DILATOR (July 26, 1983)

Other clearances for product code LIF

  • K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM (November 3, 2010)
  • K043126 — ASSIST HEADER CLEANER (February 3, 2005)
  • K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS (November 15, 2004)
  • K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM (April 27, 2004)
  • K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM (September 26, 2003)
  • K013713 — ARM AUTOMATIC REPROCESSING MACHINE (July 15, 2002)
  • K992016 — AMUKIN D (January 10, 2000)
  • K991851 — RENACLEAR DIALYZER CLEANING SYSTEM (August 30, 1999)
  • K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPS (February 10, 1999)
  • K974798 — STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (March 20, 1998)

FDA data resources