FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
K Number: K162326
·
Decision Oct 18, 2016
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
1
Review Days
60
Basic Information
- Device Name
- Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
- K Number
- K162326
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avinger, Inc
- Date Received
- August 19, 2016
- Decision Date
- October 18, 2016
- Product Code
- MCW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | FDA class 2 | Cardiovascular |
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