FDA.reportPublic FDA data

ATRAVERSE MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30298950423029895042ATRAVERSE MEDICAL1N2026-01-012611 S Coast Hwy 101 # 204 Cardiff by the Sea CA US 92007
30409936933040993693ATRAVERSE MEDICAL1N2026-01-01120 N Rios Ave Solana Beach CA US 92075

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3455351865334038K260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)DXF2026-02-27
3224881865334038K260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)DXF2026-02-27
3224882051105175K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)DXF2025-08-27
3455352051105175K252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)DXF2025-08-27
3224881224315602K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)GEI2025-08-12
3455351224315602K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)GEI2025-08-12
3224881795282925K240900HOTWIRE™ RF GuidewireDXF2024-05-01
3455351795282925K240900HOTWIRE™ RF GuidewireDXF2024-05-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXF62026-02-27
GEI22025-08-12

PMN#