Cleared Traditional

K955819 - A2 DETACHED DUAL PORT SYSTEM

K955819 is an FDA 510(k) clearance for A2 DETACHED DUAL PORT SYSTEM, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K955819 · Arrow Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
86d
Days
Class 2
Risk

K955819 is an FDA 510(k) clearance for the A2 DETACHED DUAL PORT SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Walpole, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 86 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K955819

510(k) Number K955819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 21, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
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 125
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K955819.
THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
K960572 · Arrow Intl., Inc. · Apr 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · B.Braun Medical, Inc. · Apr 1996
VASCULAR ACCESS PORT KIT
K955587 · Boston Scientific Corp · Mar 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407 · Sims Deltec, Inc. · Feb 1996
CELSITE VENOUS ACCESS SYSTEM OTW
K954297 · B.Braun Medical, Inc. · Dec 1995
SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
K935767 · Sims Deltec, Inc. · Nov 1995