Cleared Traditional

K071029 - CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)

K071029 is an FDA 510(k) clearance for CARDIODRIVE CATHETER ADVANCEMENT SYSTEM..., manufactured by Stereotaxis, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K071029 · Stereotaxis, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
135d
Days
Class 2
Risk

K071029 is an FDA 510(k) clearance for the CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 24, 2007 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K071029

510(k) Number K071029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2007
Decision Date August 24, 2007
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 686
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K071029.
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552 · Merit Medical Systems, Inc. · Dec 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705 · Asahi Intecc Co., Ltd. · Oct 2007
ASAHI PTCA GUIDE WIRE, X-TREME
K072431 · Asahi Intecc Co., Ltd. · Sep 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · Asahi Intecc Co., Ltd. · Jul 2007
RUNTHROUGH NS
K063695 · Terumo Medical Corp. · Apr 2007
COOK MICROWIRE WIRE GUIDE
K070410 · Cook, Inc. · Apr 2007