Cleared Special

K052841 - MIRA-FLEX 18 MICROCATHETER

K052841 is an FDA 510(k) clearance for MIRA-FLEX 18 MICROCATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 62-day FDA review.

K052841 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
62d
Days
Class 2
Risk

K052841 is an FDA 510(k) clearance for the MIRA-FLEX 18 MICROCATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 8, 2005 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052841

510(k) Number K052841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date December 08, 2005
Days to Decision 62 days
Submission Type Special
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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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 176
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K052841.
MERCATOR MICROSYRINGE II INFUSION CATHETER
K062752 · Mercator Medsystems, Inc. · Dec 2006
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · Cook Incorporated · Mar 2006
ECHELON MICRO CATHETER
K051990 · Micro Therapeutics, Inc. · Jan 2006
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044
K052738 · Veinrx, Inc. · Dec 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · Cordis Neurovascular, Inc. · Apr 2005
PIVOT STEERABLE MICROCATHETER
K050630 · Boston Scientific - Precision Vascular · Mar 2005
K052841 · MIRA-FLEX 18 MICROCATHETER
Download PDF FDA Summary Cook, Inc.