NORTHEAST SCIENTIFIC, INC.

FDA Device Registration & Listing · Waterbury, CT, US · Registration 3005467144

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005467144
FEI Number
3005467144
Entity Name
NORTHEAST SCIENTIFIC, INC.
City/State/Country
Waterbury, CT, US
Establishment Address
2142 Thomaston Ave, Waterbury, CT 06704, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
NORTHEAST SCIENTIFIC, INC. (Owner Number: 9079660)
Owner / Operator Contact Address
2142 Thomaston Avenue, --, Waterbury, CT 06704, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NES Reprocessed Visions PV 14P RX Digital IVUS Catheter NES Reprocessed Visions PV 18 Digital IVUS Catheter ViewFlex™ Eco Reprocessed ICE Catheter ViewFlex Xtra Reprocessed ICE Catheter NES Reprocessed RF Stylet (RFS) NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter NES Reprocessed Varicose Vein RF Catheter 700004 Vein Ablation Pack 700005 Vein Ablation Pack

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2020-08-18
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2020-08-18
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-05-13
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2025-05-13
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-07-20
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-07-20
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2018-03-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-03-28
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2023-07-11
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-07-11
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2011-12-13
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2019-02-08

Official Correspondent

Steven Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORTHEAST SCIENTIFIC, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K251211 ABBOTT MEDICAL ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ 2025-05-23
K251231 ABBOTT MEDICAL ViewFlex™ X ICE Catheter, Sensor Enabled™ 2025-05-20
K232130 Surgical Instrument Services and Savings, Inc. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter 2023-12-15
K230934 ABBOTT MEDICAL ViewFlex™ Eco Reprocessed ICE Catheter 2023-05-03
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0018-2026 Northeast Scientific Inc. 2
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.
Z-0019-2026 Northeast Scientific Inc. 2
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.
Z-0020-2026 Northeast Scientific Inc. 2
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.
Z-0021-2026 Northeast Scientific Inc. 2
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.
Z-0022-2026 Northeast Scientific Inc. 2
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.
Z-0023-2026 Northeast Scientific Inc. 2
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.
Z-0024-2026 Northeast Scientific Inc. 2
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.
Z-0025-2026 Northeast Scientific Inc. 2
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005467144. Last updated year: 2026. Please use registration number 3005467144 when referencing this establishment in official correspondence.
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