FDA 510(k) Application Details - K132197

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K132197
Device Name	Catheter, Percutaneous
Applicant	PENDRACARE INTERNATIONAL, B.V. 7205 LAKETREE DR RALEIGH, NC 27615 US Other 510(k) Applications for this Company
Contact	TOM NOLAN Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2013
Decision Date	08/12/2013
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