Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221914
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K221914
Device Name
Introducer, Catheter
Applicant
Contract Medical International GmbH
Lauensteiner Strasse 37
Dresden 01277 DE
Other 510(k) Applications for this Company
Contact
Juliana Vaz Nuernberger
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2022
Decision Date
07/29/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact