← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MJN — Catheter, Intravascular Occluding, Temporary

DEVICE CLASS
Class II
REGULATION
21 CFR 870.4450
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K243795Prytime Medical Devices, Inc. · 510k2025-09-05
K251358Philips Image Guided Therapy Devices · 510k2025-06-24

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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