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Reprocessed Intravascular Ultrasound Catheter

FDA product code OWQ · 31 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1200
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-10-11 – 2026-06-29

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

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