DeviceClearance

Impella CP Introducer— 510(k) K192769

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K192769 for Impella CP Introducer, Substantially Equivalent on 2019-11-18. 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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More clearances from Abiomed, Inc.

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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 K192769

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 K192769.

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