DeviceClearance

INTRACARDIAC SUMP 12010— 510(k) K850385

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K850385 for INTRACARDIAC SUMP 12010, Substantially Equivalent on 1985-04-29. Applicant: Dlp, Inc.. Device class: 2.

Clearance details

Applicant
Dlp, 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
Traditional
Location
Grand Rapids, MI, US
Download summary PDFView on FDA.gov ↗

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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 K850385

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 K850385.

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