Accusafe Transseptal Guidewire (GTR31180, GTR31230)— 510(k) K240246

Substantially Equivalent

Synaptic Medical Corporation

FDA 510(k) clearance K240246 for Accusafe Transseptal Guidewire (GTR31180, GTR31230), Substantially Equivalent on 2024-07-26. Applicant: Synaptic Medical Corporation.

Clearance details

Applicant: Synaptic Medical Corporation
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2024-01-30
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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.