14F iSLEEVE Introducer Set
FDA 510(k) K233503 · Boston Scientific Corporation
510(k) numberK233503
Submission
- Device name
- 14F iSLEEVE Introducer Set
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- October 31, 2023
- Decision date
- November 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was 14F iSLEEVE Introducer Set cleared by the FDA?
14F iSLEEVE Introducer Set (K233503) received a 510(k) decision of Substantially Equivalent on November 30, 2023, 30 days after the submission was received.
What is the product code of K233503?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.