1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
FDA 510(k) clearance K140944 · decided 2014-08-22
Clearance details
- K-number
- K140944
- Device name
- 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
- Applicant
- Atheromed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-04-14
- Decision date
- 2014-08-22
- Days to decision
- 130 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.