Cleared Traditional

K070003 - POWER INJECTABLE IMPLANTABLE INFUSION P...

K070003 is the FDA 510(k) clearance for POWER INJECTABLE IMPLANTABLE INFUSION P... by Medcomp. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K070003 · Medcomp · General Hospital
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May 2007
Decision
132d
Days
Class 2
Risk

K070003 is an FDA 510(k) clearance for the POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AN.... Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on May 15, 2007 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.

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Submission Details

510(k) Number K070003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date May 15, 2007
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 62
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K070003.
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
TITANIUM POWERPORT ISP IMPLANTED PORT
K072215 · C.R. Bard, Inc. · Nov 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377 · C.R. Bard, Inc. · Jan 2007
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
K061424 · Aesculap, Inc. · Jul 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812 · C.R. Bard, Inc. · Jul 2006