Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K210235 |
Device Name |
Verrata PLUS Pressure Guide Wire |
Applicant |
Volcano Corporation |
3721 Valley Centre Drive, Ste 500 |
San Diego,
CA
92130
|
|
Applicant Contact |
Leilani Taylor |
Correspondent |
Volcano Corporation |
3721 Valley Centre Drive, Ste 500 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Leilani Taylor |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/28/2021 |
Decision Date | 04/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|