← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DYB — Introducer, Catheter

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1340
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
37
510(K)/PMA CLEARANCES
510k: 37
0
RECALL ENTRIES

Recent clearances

K261529Hartman Medical Group, LLC · 510k2026-07-06
K261242Pendracare · 510k2026-06-25
K261950Health Line International Corporation · 510k2026-06-22
K261492CenterPoint Systems, LLC · 510k2026-06-05
K260606Echo Medical, LLC · 510k2026-04-29
K254248Cardiocycle Medical(Suzhou) Co., Ltd. · 510k2026-04-23
K254279Edwards Lifesciences · 510k2026-04-17
K260091Inquis Medical · 510k2026-04-13

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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