K242248
- 510(k) number
- K242248
- Device name
- Introducer Sheath Kits
- Applicant
- Beijing Demax Medical Technology Co.,Ltd CN
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-08-22
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.