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FDA 510(k) Applications Submitted by ONSET MEDICAL CORPORATION
FDA 510(k) Number
Submission Date
Device Name
Applicant
K092014
07/06/2009
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
ONSET MEDICAL CORPORATION
K061009
04/12/2006
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
ONSET MEDICAL CORPORATION
K062852
09/25/2006
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
ONSET MEDICAL CORPORATION
K043254
11/24/2004
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
ONSET MEDICAL CORPORATION
K100819
03/23/2010
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
ONSET MEDICAL CORPORATION
K121404
05/10/2012
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
ONSET MEDICAL CORPORATION
K112629
09/09/2011
ONSET ACCESS CATHETER SYSTEM
ONSET MEDICAL CORPORATION
K152498
09/01/2015
SoloPath Re-Collapsible Access System
ONSET MEDICAL CORPORATION
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