DeviceClearance

Nester Embolization Coils, Tornado Embolization Coils— 510(k) K153778

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K153778 for Nester Embolization Coils, Tornado Embolization Coils, Substantially Equivalent on 2016-05-19. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant
Cook Incorporated
Product code
Code KRD
Device class
Class 2
Regulation
21 CFR 870.3300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, IN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KRD

product code KRD
Death
119
Injury
1,869
Malfunction
7,015
Other
1
Total
9,004

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 K153778

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 K153778.

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