DeviceClearance

Tubing Pack— 510(k) K171979

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K171979 for Tubing Pack, Substantially Equivalent on 2017-10-27. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic, Inc.
Product code
Code DWF
Device class
Class 2
Regulation
21 CFR 870.4210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mounds View, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DWF

view all

More clearances from Medtronic, Inc.

view all

Adverse events under product code DWF

product code DWF
Death
106
Injury
386
Malfunction
2,323
Total
2,815

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 K171979

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 K171979.

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