Cleared Special

K014118 - MODIFICATION TO SUPERCROSS CATHETER

K014118 is the FDA 510(k) clearance for MODIFICATION TO SUPERCROSS CATHETER by Abbott Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 28-day FDA review.

K014118 · Abbott Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
28d
Days
Class 2
Risk

K014118 is an FDA 510(k) clearance for the MODIFICATION TO SUPERCROSS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on January 11, 2002 after a review of 28 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular, Inc. devices

Submission Details

510(k) Number K014118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2001
Decision Date January 11, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 575
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K014118.
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
K020161 · Guidant Corp. · Feb 2002
6F MACH1/34356-XXX
K020028 · Boston Scientific · Jan 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp · Dec 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp. · Dec 2001