Cleared Traditional

K002915 - FLEXIBLE OCCLUSION SYSTEM

K002915 is an FDA 510(k) clearance for FLEXIBLE OCCLUSION SYSTEM, manufactured by Applied Medical. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K002915 · Applied Medical · Cardiovascular device
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Jan 2001
Decision
112d
Days
Class 2
Risk

K002915 is an FDA 510(k) clearance for the FLEXIBLE OCCLUSION SYSTEM. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Applied Medical devices

FDA 510(k) Submission Details - K002915

510(k) Number K002915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date January 08, 2001
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 180
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K002915.
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · Cardiothoracic Systems, Inc. · Apr 2001
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K002767 · Semler Technologies, Inc. · Sep 2000
ENGAGE JAW INSERTS
K992980 · Novare Surgical Systems, Inc. · Jun 2000
SOFTLINE SPRING CLIP
K000098 · Novare Surgical Systems, Inc. · Apr 2000