FDA 510(k) Application Details - K011905

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K011905
Device Name	Wire, Guide, Catheter
Applicant	MAXXIM MEDICAL 1445 FLAT CREEK RD. ATHENS, TX 75751 US Other 510(k) Applications for this Company
Contact	GAIL DOHERTY 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	06/19/2001
Decision Date	08/28/2001
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