CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
FDA 510(k) K172455 · Volcano Corporation
510(k) numberK172455
Submission
- Device name
- CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- August 14, 2017
- Decision date
- October 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit cleared by the FDA?
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit (K172455) received a 510(k) decision of Substantially Equivalent on October 25, 2017, 72 days after the submission was received.
What is the product code of K172455?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.