Cleared Traditional

K081425 - COOK VASCULAR INC. VITAL-PORT VASCULAR ...

K081425 is an FDA 510(k) clearance for COOK VASCULAR INC. VITAL-PORT VASCULAR ..., manufactured by Cook Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K081425 · Cook Vascular, Inc. · General Hospital
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Sep 2008
Decision
132d
Days
Class 2
Risk

K081425 is an FDA 510(k) clearance for the COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Cook Vascular, Inc. (Vandergrift, US). The FDA issued a Cleared decision on September 30, 2008 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Vascular, Inc. devices

FDA 510(k) Submission Details - K081425

510(k) Number K081425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2008
Decision Date September 30, 2008
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 129d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 198
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K081425.
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
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PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · Smiths Medical Asd, Inc. · Mar 2010
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc. · Mar 2009
SMARTPORT CT VORTEX
K081472 · AngioDynamics, Inc. · Sep 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · C.R. Bard, Inc. · Jun 2008
JET PORT PLUS HP CATHETER SYSTEM
K072481 · Pfm Medical, Inc. · Mar 2008