Catheter, Cholangiography
FDA product code GBZ · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
24510(k) clearances
0PMA approvals
27recalls
Manufacturers
- Applied Medical Resources Corp 3
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Pilling Co. 1
- Nashville Surgical Instruments 1
- Ethicon Endo-Surgery, Inc. 1
- Boston Scientific Corporation 1
- Terumo Medical Corp. 1
- Stryker Corporation 1
- Clarus Medical Systems, Inc. 1
- Taut, Inc. 1
- O.R. Concepts, Inc. 1
- Gesco Intl., Inc. 1
- Lifestream Int'L, Inc. 1
- Cd Medical, Inc. 1
- Mentor Corp. 1
- Lazarus Medical Innovations, Inc. 1
- North Coast Medi-Tek 1
- Angiomed U.S., Inc. 1
- Intermed, Inc. 1
- Atrium Medical Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973621 | Pre-View Cholangiography ClampGBZ · Traditional | Nashville Surgical Instruments | 12/17/1997SE |
| K944790 | Flexible Laparoscopic Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 11/29/1994SE |
| K942450 | EndopathGBZ · Traditional | Ethicon Endo-Surgery, Inc. | 08/05/1994SE |
| K932228 | Microvasive Insurg Chloangiographic CatheterGBZ · Traditional | Boston Scientific Corp | 08/10/1993SE |
| K926217 | Terumo Angiographic Catheter for Laporoscopic UseGBZ · Traditional | Terumo Medical Corp. | 07/13/1993SE |
| K926143 | Angiolapcath Cholangiography KitGBZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/07/1993SESK |
| K924212 | Stryker Endoscopy Cholangiogram KitGBZ · Traditional | Stryker Corp. | 07/07/1993SESK |
| K925742 | Clarus Cholangiogram Catheter KitGBZ · Traditional | Clarus Medical Systems, Inc. | 06/01/1993SESK |
| K924981 | Operative Cholangiogram CatheterGBZ · Traditional | Taut, Inc. | 04/06/1993SE |
| K924480 | Cholangiography ClampGBZ · Traditional | Applied Medical Resources | 03/03/1993SE |
| K924128 | Cholangiography CatheterGBZ · Traditional | Applied Medical Resources | 02/10/1993SE |
| K921091 | Cholangiolapcath(Tm)GBZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/06/1992SE |
| K920643 | Laparoscopic Suction/Irrigation ProbeGBZ · Traditional | O.R. Concepts, Inc. | 05/06/1992SE |
| K914015 | Clement-Pilling Cholangiography Cath Guide/ClampGBZ · Traditional | Pilling Co. | 11/21/1991SE |
| K903709 | Surgimedics, SLP Laparoscopic Cholangiogram CathGBZ · Traditional | Lifestream Int'L, Inc. | 10/26/1990SE |
| K901520 | Wurtz Choley Clip (TM)GBZ · Traditional | Cd Medical, Inc. | 06/26/1990SE |
| K895285 | Mentor Ductal CathetersGBZ · Traditional | Mentor Corp. | 10/17/1989SE |
| K873471 | Lmi Cholangiogram TrayGBZ · Traditional | Lazarus Medical Innovations, Inc. | 10/23/1987SE |
| K870420 | PTC-6 and PTC-8 Percutaneous CholangiographyGBZ · Traditional | North Coast Medi-Tek | 04/14/1987SESD |
| K860534 | Bile Endoprosthesis SetGBZ · Traditional | Angiomed U.S., Inc. | 03/10/1986SE |
| K833059 | Suction Catheter TraysGBZ · Traditional | Intermed, Inc. | 12/12/1983SE |
| K831931 | Atrium Thoracic CatheterGBZ · Traditional | Atrium Medical Corp. | 10/04/1983SE |
| K830711 | Trachestomy & Nasal Suctioning Kit #-GBZ · Traditional | Intertex Medical | 05/02/1983SE |
| K772288 | Catheter, Cholangiogram, OperativeGBZ · Traditional | Gesco Intl., Inc. | 01/30/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3113-2026 Class II | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-3112-2026 Class II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-3111-2026 Class II | Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-0484-2024 Class II | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration… | Atrium Medical Corporation | 09/29/2023Open, Classified |
| Z-1297-2022 Class II | Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air…Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the… | Atrium Medical Corporation | 04/21/2022Open, Classified |
| Z-0560-2019 Class II | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128This recall has been initiated in response to a seal defect found in certain sterile barrier pouches… | Atrium Medical Corporation | 10/12/2018Terminated |
| Z-1222-2017 Class II | Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr… | Atrium Medical Corporation | 01/20/2017Terminated |
| Z-1221-2017 Class II | Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr… | Atrium Medical Corporation | 01/20/2017Terminated |
| Z-0583-2017 Class II | Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0582-2017 Class II | Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0581-2017 Class II | Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0580-2017 Class II | Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0579-2017 Class II | Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0578-2017 Class II | Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0577-2017 Class II | Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-0576-2017 Class II | Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | Atrium Medical Corporation | 10/26/2016Terminated |
| Z-2346-2015 Class II | Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part… | Atrium Medical Corporation | 06/19/2015Terminated |
| Z-2100-2015 Class II | Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular…Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor… | Cook Inc. | 05/28/2015Terminated |
| Z-2191-2015 Class II | American Catheter / Cholangiogram Catheter 9100 Series.Catheters were not sealed before sterilization. and was not detected through subsequent acceptance… | American Catheter Corp | 03/17/2015Terminated |
| Z-1786-2014 Class II | Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the…Several complaints were received for the metal support tube missing from the cholangiogram catheter. | Teleflex Medical | 05/16/2014Terminated |
| Z-1853-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1852-2008 | HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased number of eyelets…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1851-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly conminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1850-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top &…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1849-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14132…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1848-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |
| Z-1847-2008 | HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14120…Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated… | Atrium Medical Corporation | 05/12/2008Terminated |