Cleared Traditional

K043387 - VASCON POLARIS GUIDING CATHETER

K043387 is an FDA 510(k) clearance for VASCON POLARIS GUIDING CATHETER, manufactured by Vascon, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K043387 · Vascon, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
69d
Days
Class 2
Risk

K043387 is an FDA 510(k) clearance for the VASCON POLARIS GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascon, LLC (Miami, US). The FDA issued a Cleared decision on February 16, 2005 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K043387

510(k) Number K043387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2004
Decision Date February 16, 2005
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 878
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K043387.
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K050073 · Invatec Innovative Technologies, S.R.L. · Feb 2005
MODIFICATION TO OUTBACK CATHETER
K043534 · Lumend, Inc. · Jan 2005
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624 · Invatec Innovative Technologies, S.R.L. · Jan 2005
K043387 · VASCON POLARIS GUIDING CATHETER
Download PDF FDA Summary Vascon, LLC