← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
DEVICE CLASS
Class II
REGULATION
21 CFR 880.5970
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K260929Navi Medical Technologies · 510k2026-04-17
K252373Spectrum Vascular · 510k2025-12-16
K252792Piccolo Medical, Inc. · 510k2025-11-17
K243458Access Vascular, Inc. · 510k2025-08-01
K251212Access Vascular, Inc. · 510k2025-07-01
K243484Piccolo Medical, Inc. · 510k2025-05-29
K241587Vygon Corporation · 510k2025-02-26
K241910Navi Medical Technologies · 510k2025-01-19
Related on SPEQ
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.