Cleared Traditional

K151967 - Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter

K151967 is an FDA 510(k) clearance for Centros Long-Term Hemodialysis Catheter, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K151967 · Merit Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
263d
Days
Class 2
Risk

K151967 is an FDA 510(k) clearance for the Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Ca.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 4, 2016 after a review of 263 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151967

510(k) Number K151967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 16, 2015
Decision Date April 04, 2016
Days to Decision 263 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 131d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 123
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K151967.
NexSite HD, Hemodialysis Step Tip Catheter (60cm)
K171571 · Marvao Medical Devices, Ltd. · Nov 2017
Symetrex Long Term Hemodialysis Catheter
K171618 · Medcomp (Dba Medical Components, Inc.) · Nov 2017
NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
K161026 · Marvao Medical Devices, Ltd. · Aug 2016
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
K143567 · Marvao Medical Devices, Ltd. · Mar 2015
SYMETREX LONG TERM HEMODIALYSIS CATHETER
K140884 · Phase One Medical · Nov 2014
NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
K140492 · Marvao Medical Devices, Ltd. · Nov 2014
K151967 · Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
Download PDF FDA Summary Merit Medical Systems…