NES Reprocessed Visions PV .014P RX Digital IVUS Catheter— 510(k) K200195
Substantially EquivalentNortheast Scientific, Inc.
FDA 510(k) clearance K200195 for NES Reprocessed Visions PV .014P RX Digital IVUS Catheter, Substantially Equivalent on 2020-06-22. Applicant: Northeast Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Northeast Scientific, Inc.
- Product code
- Code OBJ
- 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
Recent devices under product code OBJ
view allMore clearances from Northeast Scientific, Inc.
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- K060676 — NES REPROCESSED ENDOSCOPIC TROCAR
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.