NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)— 510(k) K250592
Substantially EquivalentNortheast Scientific, Inc.
FDA 510(k) clearance K250592 for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700), Substantially Equivalent on 2025-05-12. 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.