Cleared Traditional

K001577 - OUTBACK CATHETER

K001577 is an FDA 510(k) clearance for OUTBACK CATHETER, manufactured by Lumend, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K001577 · Lumend, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
234d
Days
Class 2
Risk

K001577 is an FDA 510(k) clearance for the OUTBACK 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 11, 2001 after a review of 234 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

FDA 510(k) Submission Details - K001577

510(k) Number K001577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2000
Decision Date January 11, 2001
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
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 710
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K001577.
SUPERCROSS CATHETER
K001856 · Abbott Vascular, Inc. · Mar 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · Concentric Medical, Inc. · Mar 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc. · Feb 2001
NUMED Z-MED PTV CATHERERS
K003643 · NuMED, Inc. · Dec 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · Intra Luminal Therapeutics, Inc. · Sep 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · Medtronic Vascular · Aug 2000