NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter— 510(k) K223026
Substantially EquivalentNortheast Scientific, Inc.
FDA 510(k) clearance K223026 for NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, Substantially Equivalent on 2023-02-03. Applicant: Northeast Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Northeast Scientific, Inc.
- Product code
- Code OWQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waterbury, CT, US
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More clearances from Northeast Scientific, Inc.
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