DeviceClearance

Abiomed 23 Fr Sheath— 510(k) K201116

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K201116 for Abiomed 23 Fr Sheath, Substantially Equivalent on 2020-06-15. Applicant: Abiomed, Inc.. Device class: 2.

Clearance details

Applicant
Abiomed, Inc.
Product code
Code DYB
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danvers, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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 K201116

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 K201116.

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