Cleared Special

K010767 - LIFEPORT VTX ACCESS SYSTEM

K010767 is an FDA 510(k) clearance for LIFEPORT VTX ACCESS SYSTEM, manufactured by Horizon Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 27-day FDA review.

K010767 · Horizon Medical Products, Inc. · General Hospital
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Apr 2001
Decision
27d
Days
Class 2
Risk

K010767 is an FDA 510(k) clearance for the LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Horizon Medical Products, Inc. (Manchester, US). The FDA issued a Cleared decision on April 10, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Horizon Medical Products, Inc. devices

FDA 510(k) Submission Details - K010767

510(k) Number K010767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date April 10, 2001
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 126
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K010767.
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
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VAXCEL WITH PASV PORT
K030083 · Boston Scientific Corp · Jan 2003
BARDPORT X-PORT ISP PORT
K022983 · C.R. Bard, Inc. · Sep 2002
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
K010426 · Sims Deltec, Inc. · Mar 2001
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
K003006 · Arrow Intl., Inc. · Oct 2000
IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
K002770 · Hdc Corp. · Sep 2000