510(k) K182538
K182538 is an FDA 510(k) premarket notification submitted by Merit Medical Singapore Pte. , Ltd. for the device "Merit RadialFlo Arterial Catheter". The FDA issued a decision of Substantially Equivalent on Jan 16, 2019. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 16, 2019
- Date Received
- Sep 14, 2018
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
- 510(k)