Cardioblate Gemini-s Surgical Ablation Device— 510(k) K200514
Substantially EquivalentMedtronic
FDA 510(k) clearance K200514 for Cardioblate Gemini-s Surgical Ablation Device, Substantially Equivalent on 2020-06-03. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code OCL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code OCL
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- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
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- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
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Adverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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 K200514
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 K200514.
Data sourced from openFDA. This site is unofficial and independent of the FDA.