FDA 510(k) Application Details - K183357

Device Classification Name	More FDA Info for this Device
510(K) Number	K183357
Device Name	XableCath Crossing Catheter
Applicant	XableCath, Inc. 417 S. Wakara Way, Ste 3510 Salt Lake City, UT 84108-1457 US Other 510(k) Applications for this Company
Contact	Rick Gaykowski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2018
Decision Date	01/21/2019
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