Cleared Special

K072549 - TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER

K072549 is an FDA 510(k) clearance for TITANIUM POWERPORT ISP IMPLANTED PORT W..., 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 65-day FDA review.

K072549 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
65d
Days
Class 2
Risk

K072549 is an FDA 510(k) clearance for the TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE 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 November 14, 2007 after a review of 65 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.

FDA 510(k) Submission Details - K072549

510(k) Number K072549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2007
Decision Date November 14, 2007
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 287
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K072549.
MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER
K073423 · C.R. Bard, Inc. · Dec 2007
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
K072657 · Smiths Medical MD, Inc. · Dec 2007
MODIFICATION TO: T-PORT HP INFUSION PORT
K073210 · Pfm Medical, Inc. · Dec 2007
TITANIUM POWERPORT ISP IMPLANTED PORT
K072215 · C.R. Bard, Inc. · Nov 2007
T-PORT HP INFUSION PORT
K071993 · Pfm Medical, Inc. · Oct 2007
STD MED PRIMO PORT
K070911 · Std Med, Inc. · Aug 2007
K072549 · TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
Download PDF FDA Summary C.R. Bard, Inc.