Short-Term Intravascular Filter Catheter
The Short-Term Intravascular Filter Catheter (product code PNS) is a Class 2 cardiovascular device intended for short-term prevention of pulmonary embolism (PE), regulated under 870.3375. It requires 510(k) clearance and is flagged as an implant device due to its intravascular placement. The device is not classified as life-sustaining.
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Basic Information
- Product Code
- PNS
- Device Class
- FDA class 2
- Regulation Number
- 870.3375
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
For short-term prevention of pulmonary embolism (PE)
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 |
|---|---|---|---|---|
| K160747 | Angel Catheter | Jul 28, 2016 | Substantially Equivalent | Bio2 Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.