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510(k) K983373

IMPACT BALLOON DILATION CATHETER by B. Braun/Mcgaw — Product Code KNQ

K983373 is an FDA 510(k) premarket notification submitted by B. Braun/Mcgaw for the device "IMPACT BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on June 22, 1999. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. B. Braun/Mcgaw has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1999
Date Received
September 24, 1998
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 B. Braun/Mcgaw

  • K994111 — CELSITE, MODELS ST401L, ST405L (January 3, 2000)

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