MEDLINE STOPCOCK AND MANIFOLD— 510(k) K120069
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K120069 for MEDLINE STOPCOCK AND MANIFOLD, Substantially Equivalent on 2012-04-03. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code DTL
- Device class
- Class 2
- Regulation
- 21 CFR 870.4290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Adverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
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.