Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K220604 |
Device Name |
EXTesia Introducer Sheath Set |
Applicant |
Curatia Medical Co. |
830 Stewart Dr. |
Sunnyvale,
CA
94085
|
|
Applicant Contact |
Jessica Chiu |
Correspondent |
Prime Path Medtech |
1321 Upland Dr. Suite 6792 |
Houston,
TX
77043
|
|
Correspondent Contact |
Breanne Butler |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/02/2022 |
Decision Date | 04/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|