Cleared Traditional

X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 (K002054) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002054 · Appriva Medical, Inc. · Cardiovascular device
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Feb 2001
Decision
225d
Days
Class 2
Risk

K002054 is an FDA 510(k) clearance for the X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-1.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Appriva Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 225 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 Appriva Medical, Inc. devices

Submission Details

510(k) Number K002054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date February 16, 2001
Days to Decision 225 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
100d slower than avg
Panel avg: 125d · This submission: 225d
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 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K002054.
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
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CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · Merit Medical Systems, Inc. · Oct 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc. · Jan 2001
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · Cordis Corp. · Jul 2000
IN-LINE HEMOSTASIS VALVE
K990975 · Merit Medical Systems, Inc. · Mar 2000