Cleared Traditional

K063377 - POWERPORT POLYMETRIC PORT WITH 8 FR S/L...

K063377 is the FDA 510(k) clearance for POWERPORT POLYMETRIC PORT WITH 8 FR S/L... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K063377 · C.R. Bard, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
78d
Days
Class 2
Risk

K063377 is an FDA 510(k) clearance for the POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K063377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date January 25, 2007
Days to Decision 78 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K063377.
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
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
MODIFICATION TO X-PORT DUO PORT
K034065 · C.R. Bard, Inc. · Jan 2004