Vygon
20CM Leaderflex Basic Insertion Tray
12manufacturers in China registered for this device type
34catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Jiangsu (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 |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
| Jiangxi Sanxin Medtec Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Foshan Special Medical Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| 510(k) | K141026 |
| Record published | 2021-02-06 |
| Record revised | 2020-05-19 (version 5) |
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 |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Pack of 10, pack of 110, pack of 100, pack of 48, pack of 50, box of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VYLF4006 | In distribution | |
| CMS-8000 | In distribution | |
| VYLFMM1004 | In distribution | |
| AMS-7656 | In distribution | |
| VYLFN1004 | In distribution | |
| VYLF1020 | In distribution | |
| AMS-7658 | In distribution | |
| 896.038 E | In distribution | |
| CMS-8000 | In distribution | |
| VYLF2006 | In distribution | |
| VYLFN1002 | In distribution | |
| VYLF4008 | In distribution | |
| VYLF1006 | In distribution | |
| VYLF3008 | In distribution | |
| VYLF1020 | In distribution | |
| VYLF5008 | In distribution | |
| VYLFM1002 | In distribution | |
| VYLF1006 | In distribution | |
| VYLF1008 | In distribution | |
| VYLF2004 | In distribution | |
| VYLFM1003 | In distribution | |
| VYLF1004 | In distribution | |
| VYLF1008 | In distribution | |
| VYLFM1004 | In distribution | |
| VYLF1004 | In distribution | |
| VYLFN1003 | In distribution | |
| AMS-7658 | In distribution | |
| VYLF3020 | In distribution | |
| CMS-8000 | In distribution | |
| 896.038 | In distribution | |
| VYLF2008 | In distribution | |
| VYLFMM1003 | In distribution | |
| 896.038 E | In distribution | |
| AMS-7656 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 2,368 |
| Cook | Cook Incorporated | 250 |
| Cook Spectrum | Cook Incorporated | 225 |
| Jelco | ICU Medical, Inc | 104 |
| Medline | Medline Industries, Inc. | 95 |
| Deltaven Fast Flash | Delta Med SpA | 77 |
| Deltaven | Delta Med SpA | 73 |
| PowerGlide Pro | Bard Access Systems, Inc. | 63 |
| Peripheral Catheter Insertion Kit | Bard Access Systems, Inc. | 62 |
| Able Central Venous Catheter | Guangdong Baihe Medical Technology Co., Ltd. | 62 |
| Curaplex | Bound Tree Medical, LLC | 61 |
| BD Cathena™ Safety IV Catheter | Becton, Dickinson AND Company | 59 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141026 | 2014-07-30 |
| K070705 | 2007-11-30 |
| K061250 | 2006-09-29 |
| K052564 | 2006-04-05 |
| K052881 | 2006-03-02 |
| K963196 | 1997-09-09 |
| K954112 | 1996-05-09 |
| K941678 | 1995-06-26 |
| K901640 | 1990-08-10 |
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 |
|---|---|---|---|---|---|---|---|
| Vygon USA | 510(k) number | 2014-08-28 | Class II | Component design/selection | Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector. | 42250 | 2015-03-30 |
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.