Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616683

FEI Number

3004970277

Entity Name

TELEFLEX MEDICAL

City/State/Country

ANNACOTTY Limerick, IE

Establishment Address

ANNACOTTY BUSINESS PARK, ANNACOTTY Limerick -, IE

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Imager II Angiographic Catheter SpyGlass Discover Imager II IOC Catheter Vascular Dilators Vascular Dilator Set Imager II Angiographic Catheter Imager II Vascular Dilator Imager II Urology Torque Catheter GORE DrySeal Flex Introducer Sheath Imager II Sentrant Introducer Sheath with Hydrophilic Coating Imager II Catheters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-01-23
GBZ	Catheter, Cholangiography	General, Plastic Surgery	Class 1	878.4200	2007-05-31
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2016-02-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-01-23
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-09-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-02-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-09-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-09-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-06-18
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-01-14

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

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
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

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-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
3004911384	GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.	JIAXING Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616683. Last updated year: 2026. Please use registration number 9616683 when referencing this establishment in official correspondence.