Soundstar 3D Ultrasound Catheter, Model M-5723-12
FDA 510(k) K092064 · Biosense Webster, Inc.
510(k) numberK092064
Submission
- Device name
- Soundstar 3D Ultrasound Catheter, Model M-5723-12
- Applicant
- Biosense Webster, Inc.
Diamond Bar, CA, US - Received
- July 8, 2009
- Decision date
- August 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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Questions and answers
When was Soundstar 3D Ultrasound Catheter, Model M-5723-12 cleared by the FDA?
Soundstar 3D Ultrasound Catheter, Model M-5723-12 (K092064) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 30 days after the submission was received.
What is the product code of K092064?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.