FDA.reportPublic FDA data

BERLIN HEART, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30084541893008454189BERLIN HEART, INC.1Y2026-01-019391 Grogan's Mill Road Suite A-6 The Woodlands TX US 77380

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
04260090041277EXCOR® - Atrial cannula for small childrenØ 6 mm; L 25 cm; head 14 mm1.281.863.9700info@berlinheartinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1373651419304766P160035EXCOR Pediatric Ventricular Assist DeviceDSQ2017-06-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSQ12017-06-06

PMA#

GUDID#

43 records. Showing 1-40. Next