Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K102473
Device Classification Name
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
More FDA Info for this Device
510(K) Number
K102473
Device Name
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON, NY 12965 US
Other 510(k) Applications for this Company
Contact
NICHELLE LAFLESH
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
OMZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2010
Decision Date
12/09/2010
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