DeviceClearance

WATCHMAN TruSeal Access System— 510(k) K180864

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K180864 for WATCHMAN TruSeal Access System, Substantially Equivalent on 2018-07-20. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant
Boston Scientific
Product code
Code DQY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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 K180864

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 K180864.

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