Cleared Traditional

K093414 - PORT-A-CATH POWER P.A.C. IMPLANTABLE VE...

K093414 is the FDA 510(k) clearance for PORT-A-CATH POWER P.A.C. IMPLANTABLE VE... by Smiths Medical Asd, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K093414 · Smiths Medical Asd, Inc. · General Hospital
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Mar 2010
Decision
119d
Days
Class 2
Risk

K093414 is an FDA 510(k) clearance for the PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 1, 2010 after a review of 119 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K093414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2009
Decision Date March 01, 2010
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 99
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K093414.
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
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DIGNITY POWER INJECTABLE TITANIUM PORT
K120281 · Medical Components, Inc. · Sep 2012
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
K101017 · AngioDynamics, Inc. · Jun 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