Cleared Traditional

COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (K081425) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 42
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K081425.
POWERPORT IMPLANTABLE PORT
K133335 · C.R. Bard, Inc. · Feb 2014
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K122899 · C.R. Bard, Inc. · Nov 2012
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
K090512 · C.R. Bard, Inc. · Mar 2009
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · C.R. Bard, Inc. · Jun 2008
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423 · C.R. Bard, Inc. · Dec 2007
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
K072549 · C.R. Bard, Inc. · Nov 2007