Cleared Special

CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) - FDA 510(k) Clearance

Class I Immunology device.

K013866 · Boston Scientific · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
23d
Days
Class 1
Risk

K013866 is an FDA 510(k) clearance for the CONVOY ADVANCED DELIVERY SHEATH KIT. Classified as Fab, Rhodamine, Antigen, Antiserum, Control (product code DBY), Class I - General Controls.

Submitted by Boston Scientific (San Jose, US). The FDA issued a Cleared decision on December 14, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5520 - the FDA immunology device 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 devices

Submission Details

510(k) Number K013866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date December 14, 2001
Days to Decision 23 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DBY Fab, Rhodamine, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.