Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle— 510(k) K151936

Unknown

Synaptic Medical Limited

FDA 510(k) clearance K151936 for Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle, Unknown on 2015-12-04. Applicant: Synaptic Medical Limited.

Clearance details

Applicant: Synaptic Medical Limited
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2015-07-14
Decision date: 2015-12-04
Decision: Unknown
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.