Cleared Traditional

K991601 - DUAL LUMEN CATHETER, MODEL DL-35-90

K991601 is an FDA 510(k) clearance for DUAL LUMEN CATHETER, manufactured by Endologix, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K991601 · Endologix, Inc. · Cardiovascular device
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Oct 1999
Decision
171d
Days
Class 2
Risk

K991601 is an FDA 510(k) clearance for the DUAL LUMEN CATHETER, MODEL DL-35-90. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Endologix, Inc. (Irvine, US). The FDA issued a Cleared decision on October 28, 1999 after a review of 171 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 Endologix, Inc. devices

FDA 510(k) Submission Details - K991601

510(k) Number K991601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date October 28, 1999
Days to Decision 171 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 125d · This submission: 171d
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 659
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K991601.
5F GUIDING CATHETER
K000598 · Guidant Corp. · Mar 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · Advanced Cardiovascular Systems, Inc. · Feb 2000
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
K991059 · Spectranetics Corp. · Nov 1999
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
K990707 · Medtronics Interventional Vascular · Mar 1999