FDA.reportPublic FDA data

NUVASCULAR INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30300038493030003849NUVASCULAR INC.1N2026-01-01141 Innovation Dr Ste 100 Irvine CA US 92617

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850072397566HARBOR - HARBOR Occlusion Device1-855-688-2728customerservice@nuvascular.com
00850072397573HARBOR - HARBOR Occlusion Device1-855-688-2728customerservice@nuvascular.com
00850072397597HARBOR - HARBOR Occlusion Device1-855-688-2728customerservice@nuvascular.com
00850072397603HARBOR - HARBOR Occlusion Device18556882728customerservice@nuvascular.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3416511293905129K250133HARBOR Occlusion DeviceKRD2025-07-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KRD12025-07-09

PMN#

GUDID#