Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K161887 |
Device Name |
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip |
Applicant |
Volcano Corporation |
3721 Valley Centre Drive Suite 500 |
San Diego,
CA
92130
|
|
Applicant Contact |
Brian Park |
Correspondent |
Volcano Corporation |
3721 Valley Centre Drive Suite 500 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Brian Park |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/11/2016 |
Decision Date | 09/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|