Cleared Traditional

K080700 - DUOFLO CATHETER

K080700 is an FDA 510(k) clearance for DUOFLO CATHETER, manufactured by Thermopeutix, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K080700 · Thermopeutix, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
199d
Days
Class 2
Risk

K080700 is an FDA 510(k) clearance for the DUOFLO CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Thermopeutix, Inc. (San Diego, US). The FDA issued a Cleared decision on September 26, 2008 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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.

FDA 510(k) Submission Details - K080700

510(k) Number K080700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date September 26, 2008
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MJN Catheter, Intravascular Occluding, Temporary

All 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K080700.
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
K091504 · Micrus Endovascular Corporation · Jun 2009
FLOCONTROL , MODEL 1028
K090970 · Coaxia, Inc. · Jun 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · Ev3, Inc. · Apr 2009
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · Micrus Endovascular Corporation · Aug 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · Possis Medical, Inc. · Jun 2008
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · LeMaitre Vascular, Inc. · Aug 2007