K132943

Substantially Equivalent

INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE

Applicant: Synaptic Medical Limited
Product code: DRC
Advisory panel: Cardiovascular
Date received: 2013-09-19
Decision date: 2014-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.