Cleared Traditional

Presto Inflation Device

K143522 · C.R. Bard, Inc. · Cardiovascular
Jan 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K143522 is an FDA 510(k) clearance for the Presto Inflation Device, a Syringe, Balloon Inflation (Class II — Special Controls, product code MAV), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 12, 2015, 31 days after receiving the submission on December 12, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K143522 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2014
Decision Date January 12, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MAV — Syringe, Balloon Inflation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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