Cleared Traditional

K152625 - MMS Guide Catheter

K152625 is an FDA 510(k) clearance for MMS Guide Catheter, manufactured by Micro Medical Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K152625 · Micro Medical Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
176d
Days
Class 2
Risk

K152625 is an FDA 510(k) clearance for the MMS Guide Catheter. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Medical Solutions, Inc. (Quincy, US). The FDA issued a Cleared decision on March 9, 2016 after a review of 176 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 - K152625

510(k) Number K152625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date March 09, 2016
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 168
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K152625.
Bullfrog Micro-Infusion Device
K161402 · Mercator Medsystems, Inc. · Aug 2016
CrossCath Support Catheter
K161801 · Cook Incorporated · Jul 2016
Bullfrog Micro-Infusion Device
K153501 · Mercator Medsystems, Inc. · Apr 2016
ClariVein IC
K153502 · Vascular Insights, LLC · Jan 2016
Direxion Torqueable Microcatheter
K142259 · Boston Scientific Corp · Sep 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · Boston Scientific · May 2014