DeviceClearance

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System— 510(k) K190634

Substantially Equivalent

Cardiovascular Systems, Inc.

FDA 510(k) clearance K190634 for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Substantially Equivalent on 2019-07-02. Applicant: Cardiovascular Systems, Inc.. Device class: 2.

Clearance details

Applicant
Cardiovascular Systems, Inc.
Product code
Code MCW
Device class
Class 2
Regulation
21 CFR 870.4875
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St.Paul, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Cardiovascular Systems, Inc.

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Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

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 K190634

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 K190634.

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