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510(k) K130566

BASIXTOUCH by Merit Medical Systems, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2013
Date Received
March 4, 2013
Clearance Type
Special
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

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Other clearances for product code MAV

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