← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5965
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260916Portal Access, Inc. · 510k2026-06-17
K252478Bard Access Systems, Inc. · 510k2025-09-05
K251253Bard Access Systems, Inc. · 510k2025-06-18
K242328Bard Access Systems, Inc. · 510k2024-10-31

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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