Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
FDA 510(k) clearance K202049 · decided 2021-09-07
Clearance details
- K-number
- K202049
- Device name
- Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
- Applicant
- Applied Medical Resources Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-07-24
- Decision date
- 2021-09-07
- Days to decision
- 410 days
- Clearance type
- Special
- Product code
- DXE
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.