Vygon
Premicath 28 G (1 FR) 20 CM Catheter With Stylet AND Split Cannula Introducer
5manufacturers in China registered for this device type
50catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Vygon Corp., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| 510(k) | K954302 |
| Record published | 2020-03-19 |
| Record revised | 2021-02-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 0 to 40 °C |
| Packaging | Pack of 5, pack of 4, pack of 10, pack of 20 |
| Sizes | Outer diameter 24 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1261.20N | In distribution | |
| VYPL4D1003-1 | In distribution | |
| 1261.153A | Outer Diameter 24 mm | In distribution |
| VYPL5T0001 | In distribution | |
| VYPL3S3003SK-1 | In distribution | |
| VYPL4D3003LR | In distribution | |
| VYPL5T1003-1 | In distribution | |
| VYPL4S1001 | In distribution | |
| VYPL4S3003SK-1 | In distribution | |
| VYPL4S1003-1 | In distribution | |
| VYPL6T1001 | In distribution | |
| CMS-207 | In distribution | |
| 1261.203A | Outer Diameter 24 mm | In distribution |
| VYPL5D3003A | In distribution | |
| VYPL5T3003A | In distribution | |
| VYPL6T1001 | In distribution | |
| 1261.205A | Outer Diameter 24 mm | In distribution |
| VYPL5D1003 | In distribution | |
| VYPL6T0001 | In distribution | |
| 1261.20N | In distribution | |
| VYPL3S1003-1 | In distribution | |
| VYPL5T1001 | In distribution | |
| VYPL5D3003C | In distribution | |
| 1261.208A | Outer Diameter 24 mm | In distribution |
| VYPL4S1003 | In distribution | |
| VYPL5T3003SK-1 | In distribution | |
| VYPL5D3003SK | In distribution | |
| 1261.306A | Outer Diameter 24 mm | In distribution |
| VYPL5D3003S | In distribution | |
| VYPL5D0001 | In distribution | |
| VYPL4S1001LW-1 | In distribution | |
| VYPL4S3003SK | In distribution | |
| VYPL5D1001 | In distribution | |
| 1261.306A | Outer Diameter 24 mm | In distribution |
| VYPL4D3003SK-1 | In distribution | |
| VYML4D3001SK-1 | In distribution | |
| VYPL4S3003A | In distribution | |
| VYPL5D3003SK-1 | In distribution | |
| 1261.203A | Outer Diameter 24 mm | In distribution |
| VYPL5D1003-1 | In distribution | |
| VYPL5T3003C | In distribution | |
| 1261.205A | Outer Diameter 24 mm | In distribution |
| VYPL4S1001 | In distribution | |
| VYPL5D1001LW | In distribution | |
| VYPL4S3003S | In distribution | |
| VYPL5T1003 | In distribution | |
| VYPL5T1001 | In distribution | |
| 1261.207A | Outer Diameter 24 mm | In distribution |
| VYPL5D1001 | In distribution | |
| VYPL6T1003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241587 | 2025-02-26 |
| K062425 | 2006-09-15 |
| K051690 | 2005-08-19 |
| K041468 | 2004-09-09 |
| K993052 | 2000-08-03 |
| K993442 | 2000-08-03 |
| K983544 | 1999-01-13 |
| K954302 | 1996-06-17 |
| K954638 | 1996-04-22 |
| K903648 | 1991-03-07 |
| K897168 | 1990-04-23 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vygon MFG | 510(k) number | 2017-07-24 | Class II | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing g | 300 units | 2019-11-07 |
| Vygon USA | 510(k) number | 2005-06-27 | Not classified | Other | Guidewire protuding from tip of the catheter | 243 units | 2005-10-31 |
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.