Device Classification Name |
Transducer, Pressure, Catheter Tip
|
510(k) Number |
K190852 |
Device Name |
Zurich Pressure Guidewire System Model 100 |
Applicant |
Zurich Medical Inc. |
2405 Xenium Lane N |
Plymouth,
MN
55441
|
|
Applicant Contact |
Kin-Joe Sham |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2870 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/02/2019 |
Decision Date | 08/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|