Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K211525
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K211525
Device Name
Catheter, Continuous Flush
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
Other 510(k) Applications for this Company
Contact
Luke Meidell
Other 510(k) Applications for this Contact
Regulation Number
870.1210
More FDA Info for this Regulation Number
Classification Product Code
KRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2021
Decision Date
07/16/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact