Cleared Special

K073423 - MRI POWERPORT IMPLANTED PORT WITH 9.6 F...

K073423 is the FDA 510(k) clearance for MRI POWERPORT IMPLANTED PORT WITH 9.6 F... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Special 510(k) pathway after a 14-day FDA review.

K073423 · C.R. Bard, Inc. · General Hospital
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Dec 2007
Decision
14d
Days
Class 2
Risk

K073423 is an FDA 510(k) clearance for the MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on December 19, 2007 after a review of 14 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

Submission Details

510(k) Number K073423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2007
Decision Date December 19, 2007
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 109
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K073423.
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
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
POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
K070003 · Medcomp · May 2007