510(k) K172266
K172266 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "Dynarex Three-Way Stopcock". The FDA issued a decision of Substantially Equivalent on March 14, 2018. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Dynarex Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2018
- Date Received
- July 27, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stopcock, I.V. Set
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type