← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

DEVICE CLASS
Class II
REGULATION
21 CFR 870.4210
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
10
510(K)/PMA CLEARANCES
510k: 10
0
RECALL ENTRIES

Recent clearances

K260195Medtronic, Inc. · 510k2026-04-23
K250937LivaNova USA, Inc. · 510k2026-03-11
K260043Smart Reactors · 510k2026-02-23
K253203Medtronic, Inc. · 510k2026-02-19
K253671Sorin Group Italia S.R.L. · 510k2026-01-30
K253998Medtronic, Inc. · 510k2026-01-20
K253106AngioDynamics, Inc. · 510k2025-10-24
K250283LivaNova USA, Inc. · 510k2025-07-10

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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