510(k) K133280
K133280 is an FDA 510(k) premarket notification submitted by Terumo (Philippines) Corporation for the device "TERUMO SURFLO I.V. CATHETER". The FDA issued a decision of Substantially Equivalent on Jun 12, 2014. 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. Terumo (Philippines) Corporation has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 2014
- Date Received
- Oct 25, 2013
- Clearance Type
- Traditional
- 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)