Cleared Special

K090512 - POWERPORT DUO M.R.I. IMPLANTED PORT WIT...

K090512 is the FDA 510(k) clearance for POWERPORT DUO M.R.I. IMPLANTED PORT WIT... 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 29-day FDA review.

K090512 · C.R. Bard, Inc. · General Hospital
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Mar 2009
Decision
29d
Days
Class 2
Risk

K090512 is an FDA 510(k) clearance for the POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYUR.... 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 March 27, 2009 after a review of 29 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 K090512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2009
Decision Date March 27, 2009
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 105
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K081311 · C.R. Bard, Inc. · Jun 2008
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423 · C.R. Bard, Inc. · Dec 2007