Device Classification Name |
introducer, catheter
|
510(k) Number |
K183066 |
Device Name |
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model |
Applicant |
Access Scientific, LLC |
3910 Sorrento Valley Boulevard, Suite 200 |
San Diego,
CA
92121
|
|
Applicant Contact |
Martina Nguyen |
Correspondent |
Access Scientific, LLC |
3910 Sorrento Valley Boulevard, Suite 200 |
San Diego,
CA
92121
|
|
Correspondent Contact |
Martina Nguyen |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/05/2018 |
Decision Date | 07/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|