Cleared Special

K034065 - MODIFICATION TO X-PORT DUO PORT

K034065 is an FDA 510(k) clearance for MODIFICATION TO X-PORT DUO PORT, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 17-day FDA review.

K034065 · C.R. Bard, Inc. · General Hospital
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Jan 2004
Decision
17d
Days
Class 2
Risk

K034065 is an FDA 510(k) clearance for the MODIFICATION TO X-PORT DUO PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 17 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K034065

510(k) Number K034065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date January 15, 2004
Days to Decision 17 days
Submission Type Special
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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K034065.
BARDPORT TITANIUM PORTS
K050310 · Bard Access Systems, Inc. · Apr 2005
VORTEX EZ VASCULAR ACCESS PORT
K050176 · Rita Medical Systems, Inc. · Feb 2005
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · Smiths Medical MD, Inc. · Jan 2004
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · Horizon Medical Products, Inc. · Nov 2003
VORTEX MP
K032754 · Horizon Medical Products, Inc. · Sep 2003
TRIUMPH VTX WITH LIFEVALVE CATHETER
K032557 · Horizon Medical Products, Inc. · Sep 2003