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Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures

FDA product code PUM · 2 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1251
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-02-19 – 2026-09-08

Embolic protection for transcatheter intracardiac procedures

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