510(k) K242143
K242143 is an FDA 510(k) premarket notification submitted by Shandong Int Medical Instruments Co., Ltd. for the device "Angiography Injector". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Shandong Int Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2024
- Date Received
- July 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type