Cleared Traditional

K955587 - VASCULAR ACCESS PORT KIT

K955587 is an FDA 510(k) clearance for VASCULAR ACCESS PORT KIT, manufactured by Boston Scientific Corp. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K955587 · Boston Scientific Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
105d
Days
Class 2
Risk

K955587 is an FDA 510(k) clearance for the VASCULAR ACCESS PORT KIT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 21, 1996 after a review of 105 days - within the typical 510(k) review window.

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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K955587

510(k) Number K955587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1995
Decision Date March 21, 1996
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 235
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K955587.
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
THERAPORT VASCULAR ACCESS SYSTEM
K960350 · Biocontrol Technology, Inc. · Apr 1996
A2 DETACHED DUAL PORT SYSTEM
K955819 · Arrow Intl., Inc. · Mar 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407 · Sims Deltec, Inc. · Feb 1996
STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM
K953529 · Strato/Infusaid, Inc. · Jan 1996