Cleared Traditional

LUMEND PERCUTANEOUS CATHETER (K011562) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011562 · Lumend, Inc. · Cardiovascular device
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Jan 2002
Decision
240d
Days
Class 2
Risk

K011562 is an FDA 510(k) clearance for the LUMEND PERCUTANEOUS CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Lumend, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 16, 2002 after a review of 240 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. 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 Lumend, Inc. devices

Submission Details

510(k) Number K011562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date January 16, 2002
Days to Decision 240 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 125d · This submission: 240d
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 293
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K011562.
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · Medtronic Vascular · Apr 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · Medtronic Vascular · Feb 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · C.R. Bard, Inc. · Sep 2001