Device Classification Name |
Catheter, Septostomy
|
510(k) Number |
K251007 |
Device Name |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
Applicant |
Circa Scientific, Inc. |
14 Inverness Dr E, Suite H-136 |
Englewood,
CO
80112
|
|
Applicant Contact |
Jennifer Willner |
Correspondent |
JW Regulatory Consulting LLC |
406 Wacouta St, Suite 417 |
St. Paul,
MN
55101
|
|
Correspondent Contact |
Jennifer Willner |
Regulation Number | 870.5175 |
Classification Product Code |
|
Date Received | 04/01/2025 |
Decision Date | 05/01/2025 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|