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510(k) K042449

DOLPHIN INFLATION DEVICE by Sedat S.A. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2005
Date Received
September 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Sedat S.A.

  • K082755 — SEDAT FLAMINGO (December 15, 2008)
  • K080472 — SEDAT MYSHELL LITE (April 23, 2008)
  • K060010 — NAUTIFLUX (August 4, 2006)
  • K040498 — MYSHELL (July 2, 2004)

Other clearances for product code MAV

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)