Chameleon PTA Balloon Catheter
FDA 510(k) clearance K163231 · decided 2017-01-17
Clearance details
- K-number
- K163231
- Device name
- Chameleon PTA Balloon Catheter
- Applicant
- Av Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-17
- Decision date
- 2017-01-17
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tel-Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6 recall (Z-0257-2025) | Covidien LP | 2024-10-29 |
| Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with recall (Z-0557-2022) | Covidien Llc | 2022-02-03 |