PATIENT CABLE— 510(k) K080112
Substantially EquivalentMed-Dyne
FDA 510(k) clearance K080112 for PATIENT CABLE, Substantially Equivalent on 2008-06-20. Applicant: Med-Dyne. Device class: 2.
Clearance details
- Applicant
- Med-Dyne
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, KY, US
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Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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 K080112
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080112.
Data sourced from openFDA. This site is unofficial and independent of the FDA.