Catheter, Infusion, Syringe
The syringe infusion catheter is a cardiovascular device used to deliver physician-specified fluids either to the perivascular space (around blood vessels) or intraluminally within vessels during cardiac or vascular procedures. It is classified as FDA Class 2 under regulation 870.1210 in the Cardiovascular specialty, requiring 510(k) premarket notification. Product code NPG is not eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NPG
- Device Class
- FDA class 2
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To provide physician specified fluids both perivascular or intraluminal to the perivascular space.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222185 | Stratus Infusion Catheter | Apr 13, 2023 | Substantially Equivalent | Intervene, Inc. |