SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION— 510(k) K940804

Substantially Equivalent

Peripheral Systems Group

FDA 510(k) clearance K940804 for SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION, Substantially Equivalent on 1994-06-10. Applicant: Peripheral Systems Group.

Clearance details

Applicant: Peripheral Systems Group
Product code: Code ITX
Advisory panel: Radiology
Date received: 1994-02-07
Decision date: 1994-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.