PLACER MODEL 6232 STEERABLE STYLET— 510(k) K000955

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K000955 for PLACER MODEL 6232 STEERABLE STYLET, Substantially Equivalent on 2000-06-16. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2000-03-24
Decision date: 2000-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.