Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140485
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K140485
Device Name
Wire, Guide, Catheter
Applicant
LAKE REGION MEDICAL
340 LAKE HAZELTINE DRIVE
CHASKA, MN 55318 US
Other 510(k) Applications for this Company
Contact
MATHEW PEXA
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/2014
Decision Date
03/27/2014
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