Stratus Infusion Catheter
FDA 510(k) K222185 · Intervene, Inc.
510(k) numberK222185
Submission
- Device name
- Stratus Infusion Catheter
- Applicant
- Intervene, Inc.
South San Francisco, CA, US - Received
- July 22, 2022
- Decision date
- April 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPG – Catheter, Infusion, Syringe
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
More from Intervene, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)QEW · Traditional | 10/22/2025SE |
Questions and answers
When was Stratus Infusion Catheter cleared by the FDA?
Stratus Infusion Catheter (K222185) received a 510(k) decision of Substantially Equivalent on April 13, 2023, 265 days after the submission was received.
What is the product code of K222185?
The FDA product code is NPG – Catheter, Infusion, Syringe, a Class II (moderate risk) device regulated under 21 CFR 870.1210.