FDA.reportPublic FDA data

WALLABY MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125438813012543881WALLABY MEDICAL1Y2026-01-0122901 Mill Creek Drive Laguna Hills CA US 92653

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2204641269822603K240917Esperance 3+ Aspiration Catheter SystemNRY2024-10-01
2204641821913622K232437Paragon 8F Balloon Guide CatheterDQY2023-10-13
2204641288423318K231056Esperance Distal Access CatheterQJP2024-03-08
2204641485804481K223139Wallaby 017 Micro CatheterKRA2023-04-25
2204641673467176K2226036F Wallaby Long SheathDQY2023-03-02
2204641048795539K211697Esperance Aspiration Catheter SystemNRY2021-11-16
2204641997215371K173711Wallaby Avenir Coil SystemHCG2018-05-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NRY22024-10-01
DQY22023-10-13
QJP12024-03-08
KRA12023-04-25
HCG12018-05-04

PMN#