EKOS PE Endovascular Device with Control System 4.0 (CS4.0)— 510(k) K200648
Substantially EquivalentEkos Corporation
FDA 510(k) clearance K200648 for EKOS PE Endovascular Device with Control System 4.0 (CS4.0), Substantially Equivalent on 2020-08-17. Applicant: Ekos Corporation. Device class: 2.
Clearance details
- Applicant
- Ekos Corporation
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bothell, WA, US
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More clearances from Ekos Corporation
view allRecalls naming K200648
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 K200648.
Data sourced from openFDA. This site is unofficial and independent of the FDA.