Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K183655
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K183655
Device Name
Introducer, Catheter
Applicant
Baylis Medical Company Inc.
2645 Matheson Blvd. East
Mississauga L4W 4J1 CA
Other 510(k) Applications for this Company
Contact
Meghal Khakhar
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
12/27/2018
Decision Date
05/20/2019
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