Cleared Traditional

K002973 - EMBOL-X INTRODUCER

K002973 is the FDA 510(k) clearance for EMBOL-X INTRODUCER by Embol-X, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K002973 · Embol-X, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2001
Decision
216d
Days
Class 2
Risk

K002973 is an FDA 510(k) clearance for the EMBOL-X INTRODUCER, MODEL CF00200. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Embol-X, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 216 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Embol-X, Inc. devices

Submission Details

510(k) Number K002973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date April 26, 2001
Days to Decision 216 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 125d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K002973.
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K003729 · St Jude Medical · Jan 2001