Cleared Traditional

K021608 - SMITHWICK CAROTID SHUNT

K021608 is an FDA 510(k) clearance for SMITHWICK CAROTID SHUNT, manufactured by Implantable Devices. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K021608 · Implantable Devices · Cardiovascular device
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Oct 2002
Decision
159d
Days
Class 2
Risk

K021608 is an FDA 510(k) clearance for the SMITHWICK CAROTID SHUNT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Implantable Devices (Tampa, US). The FDA issued a Cleared decision on October 22, 2002 after a review of 159 days - an extended review cycle.

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 Implantable Devices devices

FDA 510(k) Submission Details - K021608

510(k) Number K021608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date October 22, 2002
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
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 85
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K021608.
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · Radi Medical Systems AB · Dec 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · Guidant Corp. · Sep 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001