SHERPA PAK CARDIAC TRANSPORT SYSTEM— 510(k) K123326

Name: FDA 510(k) clearance K123326
Creator: U.S. Food and Drug Administration
Published: 2013-02-06

Substantially Equivalent

Paragonix Technologies, Inc.

FDA 510(k) clearance K123326 for SHERPA PAK CARDIAC TRANSPORT SYSTEM, Substantially Equivalent on 2013-02-06. Applicant: Paragonix Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Paragonix Technologies, Inc.
Product code: Code MSB
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2012-10-26
Decision date: 2013-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.