← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DQX — Wire, Guide, Catheter

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1330
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
24
510(K)/PMA CLEARANCES
510k: 24
0
RECALL ENTRIES

Recent clearances

K253667Sp Medical A/S · 510k2026-07-14
K261640Merit Medical Ireland , Ltd. · 510k2026-07-13
K254137Merit Medical Ireland, Ltd. · 510k2026-05-22
K260544FMD Co., Ltd. · 510k2026-03-20
K253746Lake Region Medical · 510k2026-03-19
K253262Nano4imaging GmbH · 510k2026-03-06
K253847Merit Medical Ireland, Ltd. · 510k2026-01-31
K251385Merit Medical Ireland, Ltd. · 510k2026-01-21

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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