Medical Device Manufacturer · US , Ayer , MA

Concert Medical, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2009

Recent clearances: Concert Medical Hands-Free Syringe (HFS), S-Wire Guidewire System, CONDUCTOR CORONARY GUIDEWIRE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Concert Medical, LLC Cardiovascular ✕

2 devices

1-2 of 2

Cleared Aug 18, 2016

S-Wire Guidewire System

Cardiovascular · 268d

Cleared Sep 25, 2009

CONDUCTOR CORONARY GUIDEWIRE

Cardiovascular · 241d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 23, 2026