Medline Cardiovascular Procedure Kit— 510(k) K212258
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K212258 for Medline Cardiovascular Procedure Kit, Substantially Equivalent on 2021-12-03. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code LRO
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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Adverse events under product code LRO
product code LRO- Injury
- 975
- Malfunction
- 14,038
- Other
- 2
- Total
- 15,015
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.