FDA 510(K), K140796 MEDUSA VASCULAR PLUG
FDA 510(K), K140796 MEDUSA VASCULAR PLUG
Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K140796
Device Name MEDUSA VASCULAR PLUG,
Applicant ENDOSHAPE, INC.
Regulation Number 870.3300
Classification Product Code KRD
Date Received 03/31/2014
Decision Date 12/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
Total pages: 178
Fully redacted pages: 74
Content pages: 104
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