FDA.reportPublic FDA data

Volcano AtheroMed Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088471913008847191Volcano AtheroMed Inc.1N2020-04-251530 O'Brien Drive, Suite A Menlo Park CA US 94025

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2000771285971218K182972Phoenix Atherectomy SystemMCW2018-12-20
2000771837534181K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy SystemMCW2017-08-24
2000771084096469K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMCW2015-05-26
2000771923581339K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support ClipMCW2014-12-19
2000771867817755K1409441.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIPMCW2014-08-22
2000771097788854K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW52018-12-20
DQX12008-02-26

PMN#