FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Verrata PLUS Pressure Guide Wire
K Number: K210235
·
Decision Apr 15, 2021
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
55
Review Days
77
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Basic Information
- Device Name
- Verrata PLUS Pressure Guide Wire
- K Number
- K210235
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Volcano Corporation
- Date Received
- January 28, 2021
- Decision Date
- April 15, 2021
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K170385 | CORE M2 Vascular System | Apr 6, 2017 | Substantially Equivalent |
| K160583 | REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip | Oct 26, 2016 | Substantially Equivalent |