Chrysalis Intelligence · Sponsors · Northeast Scientific, Inc.

Northeast Scientific, Inc.

Waterbury, CT, US · 4 510(k) clearances · 9 recalls

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Total clearances
4
2020-06-22 → 2025-05-12
Last 12 months
0
Product codes
3
Most recent
2025-05-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OWQ Reprocessed Intravascular Ultrasound Catheter Class II Cardiovascular 2 2025-05-12
QTF Reprocessed Atherectomy Catheter Class II Cardiovascular 1 2022-07-01
OBJ Catheter, Ultrasound, Intravascular Class II Cardiovascular 1 2020-06-22
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
8
Most recent
2025-08-29
DateSeverityStatusRecall # ProductCodeReason
2025-08-29 Class II Ongoing Z-0025-2026 NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-E… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0024-2026 NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-E… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0023-2026 NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-E… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0022-2026 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0021-2026 NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0020-2026 NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0019-2026 NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Tur… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29 Class II Ongoing Z-0018-2026 NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-… — Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2021-04-26 Class II Terminated Z-2334-2021 NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood ves… — 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-05-12 K250592 NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) OWQ Class II Cardiovascular
2023-02-03 K223026 NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter OWQ Class II Cardiovascular
2022-07-01 K220171 NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter QTF Class II Cardiovascular
2020-06-22 K200195 NES Reprocessed Visions PV .014P RX Digital IVUS Catheter OBJ Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence