Cleared Special

K042117 - PROXIS SYSTEM, MODEL EPS 101

K042117 is an FDA 510(k) clearance for PROXIS SYSTEM, manufactured by Velocimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 155-day FDA review.

K042117 · Velocimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
155d
Days
Class 2
Risk

K042117 is an FDA 510(k) clearance for the PROXIS SYSTEM, MODEL EPS 101. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Velocimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042117

510(k) Number K042117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2004
Decision Date January 07, 2005
Days to Decision 155 days
Submission Type Special
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
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 893
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K042117.
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MODIFICATION TO OUTBACK CATHETER
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AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624 · Invatec Innovative Technologies, S.R.L. · Jan 2005
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
K042381 · Acumen Medical, Inc. · Dec 2004
6F Z4 GUIDE CATHETER
K042489 · Medtronic Vascular · Dec 2004
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K042910 · Velocimed, Inc. · Nov 2004
K042117 · PROXIS SYSTEM, MODEL EPS 101
Download PDF FDA Summary Velocimed, Inc.