Stratus Infusion Catheter
FDA 510(k) clearance K222185 · decided 2023-04-13
Clearance details
- K-number
- K222185
- Device name
- Stratus Infusion Catheter
- Applicant
- Intervene, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-22
- Decision date
- 2023-04-13
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- NPG
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.