← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MOF — Guide, Wire, Catheter, Neurovasculature

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1330
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
13
510(K)/PMA CLEARANCES
510k: 13
0
RECALL ENTRIES

Recent clearances

K254006Rapid Medical Ltd. · 510k2026-07-17
K253579Scientia Vascular, Inc. · 510k2026-04-29
K252317Suzhou Zenith Vascular SciTech Limited · 510k2026-04-16
K260537Arbor Endovascular, LLC · 510k2026-03-19
K252122Shanghai Achieva Medical Suzhou Co., Ltd. · 510k2026-03-16
K260130Arbor Endovascular, LLC · 510k2026-02-13
K252011Asahi Intecc Co., Ltd. · 510k2026-02-02
K253168Arbor Endovascular, LLC · 510k2025-11-26

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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