Devices

Biliary Catheters

Model / Serial
Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
Product Description
Biliary Catheters (Models A47XX and CB0XXXXX): || Model Numbers & Description: || A4752, SYNTEL BILIARY 5F-23CM CATHETER; || A4754, SYNTEL BILIARY 5F-40CM CATHETER; || A4762, SYNTEL BILIARY 6F-23CM CATHETER; || CB052308, SYNTEL BILIARY 5F-23CM CATH; || CB054008, SYNTEL BILIARY 5F-40CM CATH; || CB062313, SYNTEL BILIARY 6F-23CM CATH. || Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.
Manufacturer
Applied Medical Resources Corp
1 Event
- Recall of Biliary Catheters

Manufacturer

Applied Medical Resources Corp

Manufacturer Address
Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
Manufacturer Parent Company (2017)
Applied Medical Corporation
Source
USFDA

3 devices with a similar name

Learn more about the data here

Applied Medical Vascular and Biliary Catheters

Model / Serial
Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots
Manufacturer
Applied Medical Resources Corporation

Biliary Catheters

Model / Serial
A47XX; CB0XXXXX | see FSN
Product Description
MD: Drainage biliary catheter; Embolectomy/thrombectomy catheter; Cholangiopancreatography catheter, single-use
Manufacturer
Applied Medical Resources distributed by Bard Medica SA

Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)

Model / Serial
Syntel Vascular Catheters and Syntel Biliary Catheters (embolectomy catheter)Syntel Vascular CathetersModel Numbers: A4403, A4405 to A4407 (inc), A4F00 to A4F08 (inc.)Lot Numbers: Multiple lots affectedARTG Number: 116754Syntel Biliary CathetersModel numbers: A4752Lot numbers: 1165670ARTG Number: 116815
Product Classification
Gastroenterology-Urology Devices
Manufacturer
Applied Medical Australia Pty Ltd

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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