Cleared Traditional

CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)

K042850 · Stereotaxis, Inc. · Cardiovascular
Aug 2006
Decision
663d
Days
Class 2
Risk

About This 510(k) Submission

K042850 is an FDA 510(k) clearance for the CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on August 9, 2006, 663 days after receiving the submission on October 15, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K042850 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2004
Decision Date August 09, 2006
Days to Decision 663 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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