DeviceClearance

PIONEER PLUS CATHETER— 510(k) K081804

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K081804 for PIONEER PLUS CATHETER, Substantially Equivalent on 2008-08-05. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic, Inc.
Product code
Code PDU
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Rosa, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PDU

product code PDU
Malfunction
793
Total
793

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K081804

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081804.

Data sourced from openFDA. This site is unofficial and independent of the FDA.