HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR— 510(k) K061070

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K061070 for HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR, Substantially Equivalent on 2006-10-13. Applicant: Hansen Medical, Inc..

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2006-04-17
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, 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.