Cleared Special

K140329 - RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT

K140329 is an FDA 510(k) clearance for RENEGADE HI-FLO MICROCATHETER, manufactured by Boston Scientific. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Special 510(k) pathway after a 94-day FDA review.

K140329 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
94d
Days
Class 2
Risk

K140329 is an FDA 510(k) clearance for the RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on May 15, 2014 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K140329

510(k) Number K140329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2014
Decision Date May 15, 2014
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 173
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K140329.
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K140329 · RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
Download PDF FDA Summary Boston Scientific