Cleared Traditional

K062414 - VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET

K062414 is an FDA 510(k) clearance for VORTEX CT PORT ACCESS SYSTEM AND LIFEGU..., manufactured by Rita Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K062414 · Rita Medical Systems, Inc. · General Hospital
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Feb 2007
Decision
168d
Days
Class 2
Risk

K062414 is an FDA 510(k) clearance for the VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Rita Medical Systems, Inc. (Manchester, US). The FDA issued a Cleared decision on February 1, 2007 after a review of 168 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Rita Medical Systems, Inc. devices

FDA 510(k) Submission Details - K062414

510(k) Number K062414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date February 01, 2007
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K062414.
T-PORT HP INFUSION PORT
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POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
K070003 · Medcomp · May 2007
POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER
K063377 · C.R. Bard, Inc. · Jan 2007
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
K061424 · Aesculap, Inc. · Jul 2006
POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE
K060812 · C.R. Bard, Inc. · Jul 2006