Cleared Traditional

K021802 - STEREOTAXIS CATHETER ADVANCER SYSTEM

K021802 is the FDA 510(k) clearance for STEREOTAXIS CATHETER ADVANCER SYSTEM by Stereotaxis, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K021802 · Stereotaxis, Inc. · Cardiovascular device
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Apr 2003
Decision
309d
Days
Class 2
Risk

K021802 is an FDA 510(k) clearance for the STEREOTAXIS CATHETER ADVANCER SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on April 8, 2003 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Stereotaxis, Inc. devices

Submission Details

510(k) Number K021802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2002
Decision Date April 08, 2003
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 125d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 599
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