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510(k) K143522

Presto Inflation Device by C.R. Bard, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2015
Date Received
December 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
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  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 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)