DeviceClearance

Medtronic Temporary External Pacemaker 53401— 510(k) K162054

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K162054 for Medtronic Temporary External Pacemaker 53401, Substantially Equivalent on 2016-10-18. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant
Medtronic, Inc.
Product code
Code DTE
Device class
Class 2
Regulation
21 CFR 870.3600
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mounds View, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DTE

view all

More clearances from Medtronic, Inc.

view all

Adverse events under product code DTE

product code DTE
Death
18
Injury
247
Malfunction
4,603
Total
4,868

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 K162054

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 K162054.

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