FDA.reportPublic FDA data

ASCEND CARDIOVASCULAR LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151680973015168097ASCEND CARDIOVASCULAR LLC1N2026-01-012501 Chatham Rd STE 5053 Springfield IL US 62704

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
00860006348007ASCEND Catalyst Live - Catalyst Live is a telepresence solution that enables collaboration in imaging, surgical, remote, and hybrid environments.8444132610information@ascendcv.com
00860006348014ASCEND InView - ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.8444132610information@ascendcv.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2269991197052712K192372ASCEND Image ViewerLLZ2020-02-14
2269991688758627

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12020-02-14

GUDID#

ASCEND InView - ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.

Ascend Cardiovascular LLC

2024-10-22