← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line

DEVICE CLASS
Class II
REGULATION
21 CFR 870.4260
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K251744Medtronic · 510k2026-01-16
K242953Sorin Group Italia S.R.L. · 510k2024-12-20
K242092Sorin Group Italia S.R.L. · 510k2024-11-18

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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