NORTHEAST SCIENTIFIC, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 1 510(k) filings: 0 Recalls: 8

Known Identifiers & Locations

FEI Numbers 3005467144
Owner Operator Numbers 9079660
Locations Covered Waterbury, CT, US

Registered Establishments (1)

Registration # Establishment Name Location Establishment Type(s) Action
3005467144 NORTHEAST SCIENTIFIC, INC. Waterbury, CT, US Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198 View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (8)

Recall # Product Description Initiation Date Status Action
Z-0018-2026 NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0019-2026 NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0020-2026 NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0021-2026 NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0022-2026 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0023-2026 NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0024-2026 NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details
Z-0025-2026 NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. 2025-08-29 Open, Classified View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.