PIONEER PLUS CATHETER, MODEL PLUS 120— 510(k) K101777

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K101777 for PIONEER PLUS CATHETER, MODEL PLUS 120, Substantially Equivalent on 2010-07-23. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2010-06-25
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.