THORACENT LLC

FDA Device Registration & Listing · Huntington, NY, US · Registration 3013337852

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
3013337852
FEI Number
3013337852
Entity Name
THORACENT LLC
City/State/Country
Huntington, NY, US
Establishment Address
120 New York Ave, Suite 6W, Huntington, NY 11743, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Thoracent, Inc. (Owner Number: 10053873)
Owner / Operator Contact Address
11 Stewart Ave, Unit 1, Suite 200, Huntington, NY 11743, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Bonastent Biliary Croc-Bite Forceps Pinza Forceps Polyp trap ITAFLEX - BITEBLOCK Bonastent Tracheal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-02-03
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2021-04-13
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2019-01-28
MNK Endoscopic Bite Block Gastroenterology, Urology Class 1 876.1500 2019-01-28
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2017-02-03

Official Correspondent

Brian Lynch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thoracent, 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
K902734 Olympus Corp. PR CANNULAS 1990-08-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013337852. Last updated year: 2026. Please use registration number 3013337852 when referencing this establishment in official correspondence.
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