FDA.reportPublic FDA data

Silk Road Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Silk Road Medical5N2027-01-01Two Scimed Place Maple Grove MN US 55311
30226278473022627847Silk Road Medical1Y2026-01-0114755 27th Avenue North Plymouth MN US 55447

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3321331674222266P140026ENROUTE TRANSCAROTID STENT SYSTEMNIM2015-05-18
3321331471279712K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterLIT2022-09-02
3538221471279712K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterLIT2022-09-02
3321331141042713K153485ENROUTE Transcarotid Neuroprotection SystemNTE2016-03-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LIT22022-09-02
NTE12016-03-10
NIM12015-05-18

PMN#