Cleared Special

K013866 - CONVOY ADVANCED DELIVERY SHEATH KIT

K013866 is an FDA 510(k) clearance for CONVOY ADVANCED DELIVERY SHEATH KIT, manufactured by Boston Scientific. The device is a Class 1 Immunology device with product code DBY cleared through the Special 510(k) pathway after a 23-day FDA review.

K013866 · Boston Scientific · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K013866

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 105d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

DBY Device Classification - Class 1, General Controls

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.

Regulatory Peers - DBY Fab, Rhodamine, Antigen, Antiserum, Control

Devices cleared under the same product code (DBY) and FDA review panel - the closest regulatory comparables to K013866.
TORFLEX TRANSSEPTAL GUIDING SHEATH
K013919 · Baylis Medical Co., Inc. · Feb 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
K013304 · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 2002
GORE INTRODUCER SHEATH
K013282 · W.L. Gore & Associates, Inc. · Dec 2001
RHODAMINE-CONJUGATED ANTISERUM
K771144 · Kent Laboratories, Inc. · Jul 1977
K013866 · CONVOY ADVANCED DELIVERY SHEATH KIT
Download PDF FDA Summary Boston Scientific