FDA.reportPublic FDA data

HELIOS CARDIO INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30208567823020856782HELIOS CARDIO INC.1N2026-01-0133 Strathmore Rd Natick MA US 01760

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
00850023375001CardiaMend - CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm1-339-707-7788support@helioscardio.com
00850023375018CardiaMend - CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm1-339-707-7788support@helioscardio.com
00850023375025CardiaMend - CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm1-339-707-7788support@helioscardio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2982731778907557K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ2021-12-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PSQ12021-12-21

PMN#

GUDID#