Cleared Traditional

K043178 - GRANTALDER RHAPSODY ACCESS PORT AND CATHETER

K043178 is an FDA 510(k) clearance for GRANTALDER RHAPSODY ACCESS PORT AND CAT..., manufactured by Grantadler Corportation. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 443-day FDA review.

K043178 · Grantadler Corportation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
443d
Days
Class 2
Risk

K043178 is an FDA 510(k) clearance for the GRANTALDER RHAPSODY ACCESS PORT AND CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Grantadler Corportation (Yorkville, US). The FDA issued a Cleared decision on February 2, 2006 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Grantadler Corportation devices

FDA 510(k) Submission Details - K043178

510(k) Number K043178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2004
Decision Date February 02, 2006
Days to Decision 443 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
314d slower than avg
Panel avg: 129d · This submission: 443d
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 229
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K043178.
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
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS ACCESS SYSTEMS WITH DUAL LAYER CATHETER
K060036 · Smiths Medical MD, Inc. · May 2006
BARDPORT TITANIUM PORTS
K050310 · Bard Access Systems, Inc. · Apr 2005
PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
K033686 · Smiths Medical MD, Inc. · Jan 2004
MODIFICATION TO X-PORT DUO PORT
K034065 · C.R. Bard, Inc. · Jan 2004