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510(k) K884715

ACHELASIA BALLOON DIALATOR by Primrose Medical, Inc. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
November 8, 1988
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 Primrose Medical, Inc.

  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881977 — PRESSURE INFUSOR (July 29, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)
  • K881978 — ENTERAL FEEDING TUBES (July 13, 1988)

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)