Cleared Traditional

K002054 - X-SEPT TRANSSEPTAL SHEATH AND TRANSITIO...

K002054 is an FDA 510(k) clearance for X-SEPT TRANSSEPTAL SHEATH AND TRANSITIO..., manufactured by Appriva Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K002054

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.

DYB Device Classification - Class 2, Special Controls

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 440
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K002054.
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
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SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
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TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · Arrow Intl., Inc. · Mar 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc. · Jan 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),
K003729 · St Jude Medical · Jan 2001
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · Daig Corp. · Nov 2000