DeviceClearance

ADVANTA GRAFT (>6MM)— 510(k) K992960

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K992960 for ADVANTA GRAFT (>6MM), Substantially Equivalent on 1999-10-01. Applicant: Atrium Medical Corp.. Device class: 2.

Clearance details

Applicant
Atrium Medical Corp.
Product code
Code DSY
Device class
Class 2
Regulation
21 CFR 870.3450
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hudson, NH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DSY

product code DSY
Death
29
Injury
694
Total
723

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 K992960

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 K992960.

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