Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K192774 |
Device Name |
BioCardia 8F Morph DNA Deflectable Guide Catheter |
Applicant |
BioCardia |
125 Shoreway Road, Suite B |
San Carlos,
CA
94070
|
|
Applicant Contact |
Patrick Lee |
Correspondent |
BioCardia |
125 Shoreway Road, Suite B |
San Carlos,
CA
94070
|
|
Correspondent Contact |
Patrick Lee |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 01/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|