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510(k) K834451

COAXIAL BALLOON GASTROESOPHAGEAL DILA by Thomas J. Fogarty, M.D. — Product Code KNQ

K834451 is an FDA 510(k) premarket notification submitted by Thomas J. Fogarty, M.D. for the device "COAXIAL BALLOON GASTROESOPHAGEAL DILA". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Thomas J. Fogarty, M.D. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
December 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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

  • K902453 — OSCILLOMETRIC PULSE DETECTION DEVICE (August 23, 1990)
  • K884154 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 27, 1988)
  • K831809 — FOGARTY OCCLUDER PAD (August 27, 1984)
  • K841310 — GASTROINTESTINAL DILATOR (July 31, 1984)
  • K831384 — COAXIAL BALLOON URETHRAL DILATOR (July 26, 1983)

Other clearances for product code KNQ

  • K122924 — CRE FIXED WIRE BALLON DILATION CATHETER (October 24, 2012)
  • K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR (November 10, 2009)
  • K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (September 25, 2009)
  • K082995 — SMART DILATOR (February 6, 2009)
  • K061937 — COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON (December 1, 2006)
  • K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR (September 21, 2006)
  • K060302 — INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED (April 11, 2006)
  • K043605 — INSCOPE 3-STAGE BALLOON DILATOR (February 4, 2005)
  • K033936 — BARD ELIMINATOR PET BALLOON DILATORS (January 14, 2004)
  • K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR (January 12, 2004)

FDA data resources