Teleflex Medical OEM LLC

FDA Device Registration & Listing · Plymouth, MN, US · Registration 3005232773

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
3005232773
FEI Number
3005232773
Entity Name
Teleflex Medical OEM LLC
City/State/Country
Plymouth, MN, US
Establishment Address
3750 Annapolis Ln N Ste 160, Plymouth, MN 55447, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Teleflex (Owner Number: 9062981)
Owner / Operator Contact Address
3015 Carrington Mill Blvd., Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Endophys Pressure Sensing Sheath Kit Uro Pass Ureteral Access Sheath Endophys Pressure Sensing Sheath

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2023-11-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-11-30
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2013-07-02
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2016-11-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-11-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2016-11-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-11-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-11-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2016-11-28
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2023-11-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-11-30

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013515223 T.K. India Pvt. Ltd. Chandigarh, IN
3004365956 Teleflex Medical de Mexico, S. de R.L. de C.V. NUEVO LAREDO Tamaulipas, MX
3010041511 Teleflex LLC (NADC) Olive Branch, MS, US
3007134520 TELEFLEX MEDICAL ATHLONE Westmeath, IE
8040412 Teleflex Medical Sdn. Bhd. KAMUNTING Perak, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005232773. Last updated year: 2026. Please use registration number 3005232773 when referencing this establishment in official correspondence.
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