Cleared Traditional

CONVOY ADVANCED DELIVERY SHEATH (K022067) - FDA 510(k) Clearance

Class I Immunology device.

K022067 · Boston Scientific · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
78d
Days
Class 1
Risk

K022067 is an FDA 510(k) clearance for the CONVOY ADVANCED DELIVERY SHEATH. 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 September 11, 2002 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific devices

Submission Details

510(k) Number K022067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2002
Decision Date September 11, 2002
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 104d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

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.