510(k) K222185
K222185 is an FDA 510(k) premarket notification submitted by Intervene, Inc. for the device "Stratus Infusion Catheter". The FDA issued a decision of Substantially Equivalent on April 13, 2023. The device falls under product code NPG (Catheter, Infusion, Syringe), a Class II device regulated under 21 CFR 870.1210. Intervene, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2023
- Date Received
- July 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Infusion, Syringe
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type
To provide physician specified fluids both perivascular or intraluminal to the perivascular space.