Cleared Special

K020012 - MODIFICATION TO RENEGADE FIBER BRAIDED ...

K020012 is an FDA 510(k) clearance for MODIFICATION TO RENEGADE FIBER BRAIDED ..., manufactured by Boston Scientific/Medi-Tech. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 26-day FDA review.

K020012 · Boston Scientific/Medi-Tech · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
26d
Days
Class 2
Risk

K020012 is an FDA 510(k) clearance for the MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific/Medi-Tech (Natick,, US). The FDA issued a Cleared decision on January 29, 2002 after a review of 26 days - a notably fast clearance cycle.

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

View all Boston Scientific/Medi-Tech devices

FDA 510(k) Submission Details - K020012

510(k) Number K020012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2002
Decision Date January 29, 2002
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 306
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