Splittable Needle Introducer
Splittable Needle Introducer 28ga (1.2F) x 20mm
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this 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 | Argon Medical Devices, Inc., 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 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K920755 |
| Record published | 2015-10-23 |
| Record revised | 2026-05-11 (version 6) |
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, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28 GA (1.2F) x 20 mm | 28 GA (1.2F) x 20 mm | 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 |
|---|---|
| K230669 | 2023-11-30 |
Recalls Naming This Product
10 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 |
|---|---|---|---|---|---|---|---|
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 8090 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 715 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 435 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 5740 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 3750 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 14,270 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2005-03-25 | Not classified | Other | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | 220 units | 2011-08-08 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2004-03-09 | Not classified | Other | Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion. | 5690 units | 2011-06-24 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2004-03-09 | Not classified | Other | Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion. | 580 units | 2011-06-24 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2004-03-09 | Not classified | Other | Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion. | 1850 units | 2011-06-24 |
Recalls
3 of these are Class II. 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 |
|---|---|---|---|---|
| 2026-06-15 | Class II | Device Design | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, in | 20 |
| 2026-06-15 | Class II | Device Design | Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, in | 6928 |
| 2024-06-14 | Class II | Employee error | Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay. | 155 |
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.