Permanent Sled Bag
FDA 510(k) K152403 · Boston Scientific
510(k) numberK152403
Submission
- Device name
- Permanent Sled Bag
- Applicant
- Boston Scientific
Fremont, CA, US - Received
- August 25, 2015
- Decision date
- September 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Permanent Sled Bag cleared by the FDA?
Permanent Sled Bag (K152403) received a 510(k) decision of Substantially Equivalent on September 22, 2015, 28 days after the submission was received.
What is the product code of K152403?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.