RITHM ID ELECTROPHYSIOLOGY CATHETER— 510(k) K133028

Clearance details

Applicant

Synaptic Medical Limited

Product code

Code DRF

Device class

Class 2

Regulation

21 CFR 870.1220

Advisory panel

Cardiovascular

Date received

2013-09-26

Decision date

2014-03-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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• K151936 — Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle2015-12-04
• K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE2014-08-29

Death

127

Injury

1,676

Malfunction

2,003

Other

1

Total

3,807

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →