← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LIT — Catheter, Angioplasty, Peripheral, Transluminal

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1250
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K260304WAVE Medical AG · 510k2026-05-20
K252512ABBOTT MEDICAL · 510k2026-02-13
K251915Natec Medical , Ltd. · 510k2025-12-18
K250706Biotronik, Inc. · 510k2025-04-04
K243704Brosmed Medical Co., Ltd. · 510k2025-02-27
K241040Natec Medical , Ltd. · 510k2024-12-18
K242419Creagh Medical Ltd. Dba Surmodics, Inc. · 510k2024-11-15

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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