Medical Device Manufacturer · US , Eden Prairie , MN

Rhythm Xience, Inc. (Rxi) - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017

Recent clearances: Guider Catheter Introducer, Flextra Steerable Introducer

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rhythm Xience, Inc. (Rxi) Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 09, 2017

Guider Catheter Introducer

Cardiovascular · 28d

Cleared Feb 27, 2017

Flextra Steerable Introducer

Cardiovascular · 20d

Data Source

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

Last updated: Sep 14, 2026