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510(k) K023907

CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER by Cordis Corp. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
November 25, 2002
Clearance Type
Special
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

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  • 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)
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