Cleared Traditional

K020693 - AORTIC CANNULA

Also marketed or referenced as:
AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101

K020693 is the FDA 510(k) clearance for AORTIC CANNULA by Embol-X, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K020693 · Embol-X, Inc. · Cardiovascular device
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Sep 2002
Decision
185d
Days
Class 2
Risk

K020693 is an FDA 510(k) clearance for the AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Embol-X, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 5, 2002 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 K020693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date September 05, 2002
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K020693.
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · Medtronic Vascular · Jan 2003
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
K023880 · Ethicon, Inc. · Dec 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · Terumo Cardiovascular Systems Corp. · Nov 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · Edwards Lifesciences, LLC · Apr 2002
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · Cobe Cardiovascular, Inc. · Oct 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular · Aug 2001