Cleared Traditional

PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A

K093858 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular
Apr 2010
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K093858 is an FDA 510(k) clearance for the PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A, a Cable, Transducer And Electrode, Patient, (including Connector) (Class II — Special Controls, product code DSA), submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on April 2, 2010, 107 days after receiving the submission on December 16, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K093858 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2009
Decision Date April 02, 2010
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2900

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