Twin-Pass® 023″ Dual Access Catheter
The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to…
The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass.023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature.
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Vascular Solutions LLC, United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K062877 |
| Record published | 2016-09-05 |
| Record revised | 2022-06-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 135 cm; catheter gauge 4 Fr |
| Distribution end date | 2019-04-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5230 | Length 135 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221470 | 2022-06-17 |
| K170544 | 2017-11-17 |
| K101625 | 2010-07-19 |
| K081846 | 2009-01-28 |
| K073585 | 2008-04-17 |
| K073200 | 2008-02-01 |
| K062877 | 2007-01-18 |
| K062627 | 2007-01-05 |
| K061565 | 2006-08-02 |
| K051395 | 2005-06-24 |
| K050168 | 2005-05-18 |
| K041909 | 2004-09-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vascular Solutions LLC | 510(k) number | 2016-09-16 | Class I | Process control | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. | 11,670 units total | 2018-05-04 |
Recalls
6 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 2990 units | 2024-06-18 |
| 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 1,745 units | 2024-06-18 |
| 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 89,121 units | 2024-06-18 |
| 2020-08-31 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 1,680 units | 2024-06-18 |
| 2020-03-16 | Class I | Process control | The inner lumen of the Langston catheter may separate from the hub during pressure injection. | 30,877 units | 2024-06-18 |
| 2017-01-12 | Class II | Error in labeling | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. | 633 | 2018-04-18 |
| 2014-05-27 | Class I | Component design/selection | The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury. | 8,580 total (US 5714) | 2015-01-30 |
| 2011-06-09 | Not classified | Packaging process control | Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouc | 23 (5 pack) boxes | 2012-04-05 |
| 2010-09-02 | Not classified | Process control | Investigation of a recent Device Experience Report has made us aware of a potential problem with our 6F Langston dual lumen pigtail catheter (Model 5540) with the following lot numbers: 548110, 548227, 548364, 548430, 548554 & 548723. Rece | 1,128 boxes ( 5pk) | 2012-04-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.