MDU5 Plus Sterile Bag
FDA 510(k) K123424 · Boston Scientific Corp
510(k) numberK123424
Submission
- Device name
- MDU5 Plus Sterile Bag
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- November 7, 2012
- Decision date
- February 20, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MDU5 Plus Sterile Bag cleared by the FDA?
MDU5 Plus Sterile Bag (K123424) received a 510(k) decision of Substantially Equivalent on February 20, 2013, 105 days after the submission was received.
What is the product code of K123424?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.