WIRION— 510(k) K200198
Substantially EquivalentCardiovascular Systems, Inc.
FDA 510(k) clearance K200198 for WIRION, Substantially Equivalent on 2020-03-18. Applicant: Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Systems, Inc.
- Product code
- Code NTE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St.Paul, MN, US
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More clearances from Cardiovascular Systems, Inc.
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- K211240 — ViperCross Support Catheters
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Adverse events under product code NTE
product code NTE- Death
- 28
- Injury
- 1,348
- Malfunction
- 771
- Total
- 2,147
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.