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510(k) K140943

MASTRO PLUS BALLOON IN-DEFLATION DEVICE by Beijing Demax Medical Technology Co.,Ltd — Product Code MAV

K140943 is an FDA 510(k) premarket notification submitted by Beijing Demax Medical Technology Co.,Ltd for the device "MASTRO PLUS BALLOON IN-DEFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on March 5, 2015. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Beijing Demax Medical Technology Co.,Ltd has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2015
Date Received
April 14, 2014
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 Beijing Demax Medical Technology Co.,Ltd

  • K242248 — Introducer Sheath Kits (August 22, 2024)
  • K222184 — Introducer Sheath Kits (February 21, 2023)
  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)

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)
  • 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)
  • K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE (December 19, 2012)

FDA data resources