Cleared Traditional

K060010 - NAUTIFLUX

K060010 is an FDA 510(k) clearance for NAUTIFLUX, manufactured by Sedat. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K060010 · Sedat · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
213d
Days
Class 2
Risk

K060010 is an FDA 510(k) clearance for the NAUTIFLUX. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Sedat (San Diego, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Sedat devices

FDA 510(k) Submission Details - K060010

510(k) Number K060010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2006
Decision Date August 04, 2006
Days to Decision 213 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
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 372
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K060010.
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
K062627 · Vascular Solutions, Inc. · Jan 2007
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
K063312 · Boston Scientific Corp · Nov 2006
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K061733 · AngioDynamics, Inc. · Aug 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
K061963 · Micrus Endovascular Corporation · Aug 2006
LANGSTON DUAL LUMEN CATHETER
K061565 · Vascular Solutions, Inc. · Aug 2006
MICRUS COURIER MICROCATHETERS
K060116 · Micrus Endovascular Corporation · May 2006