← DeviceClear
HomeDevice Clearances

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT — Advanced Cardiovascular Systems, Inc. (510(k) K946029)

ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT — Advanced Cardiovascular Systems, Inc. (510(k) K946029) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT; Applicant: Advanced Cardiovascular Systems, Inc.; Clearance track: 510(k).

Device nameACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
ApplicantAdvanced Cardiovascular Systems, Inc.
Clearance track510(k)
Submission numberK946029
DecisionSubstantially Equivalent
Decision date1995-02-24
Date received1994-12-09
Product codeDQX
Device class2
Medical specialtyCardiovascular
Applicant locationCA, US
SourceopenFDA device

🔍 Search all device clearances →