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510(k) K102648

ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK by Shenzhen Ant Hi-Tech Industrial Co., Ltd. — Product Code MAV

K102648 is an FDA 510(k) premarket notification submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. for the device "ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK". The FDA issued a decision of Substantially Equivalent on July 1, 2011. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Shenzhen Ant Hi-Tech Industrial Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
September 14, 2010
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 Shenzhen Ant Hi-Tech Industrial Co., Ltd.

  • K131770 — PRESSURE CONNECTING TUBE (February 26, 2014)
  • K091408 — DISPOSABLE PRESSURE TRANSDUCER (August 18, 2009)
  • K072696 — ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200 (May 2, 2008)

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)

FDA data resources