510(k) K251788
K251788 is an FDA 510(k) premarket notification submitted by Zhuhai DR Medical Instruments Co., Ltd. for the device "Extension tube". The FDA issued a decision of Substantially Equivalent on March 5, 2026. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Zhuhai DR Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2026
- Date Received
- June 11, 2025
- 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