510(k) K210037
K210037 is an FDA 510(k) premarket notification submitted by Mediplus (India) Limited for the device "Pluski Safe 1 Safety IV Catheter". The FDA issued a decision of Substantially Equivalent on Mar 25, 2022. 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
- Mar 25, 2022
- Date Received
- Jan 6, 2021
- 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)