HydroPICC Dual Lumen
HydroPICC Dual Lumen is a 5 Fr peripherally inserted central catheter with two separate fluid channels. The catheter body uses a radiopaque hydrophilic material and connects to extension…
HydroPICC Dual Lumen is a 5 Fr peripherally inserted central catheter with two separate fluid channels. The catheter body uses a radiopaque hydrophilic material and connects to extension tubes and Luer-lock hubs.
A suture wing supports external securement. The catheter is supplied in placement-kit configurations, and the maximum power-injection flow rate for each lumen is marked on its extension-tube clamp.
Listed Item
5F Dual Lumen Peripherally Inserted Central Marked Catheter (Mobile Kit)
Central Venous Access
The catheter provides short- or long-term access for intravenous fluids, medicines and nutrients, blood sampling, central venous pressure monitoring and specified contrast injection. Its hydrophilic catheter body has different supplied and hydrated dimensions, reaching a 5 Fr outer size after hydration.
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 | Access Vascular, 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 | Manufacturer |
| 510(k) | K213550 |
| Record published | 2022-07-14 |
| Record revised | 2024-02-08 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80002002 | In distribution | |
| 80002104 | In distribution | |
| 80H02101 | In distribution | |
| 80H02104 | In distribution | |
| 80002102 | In distribution | |
| 80002001 | In distribution | |
| 80H02102 | In distribution | |
| 90002104 | In distribution | |
| 80002101 | In distribution | |
| 80002004 | 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 |
|---|---|
| K243458 | 2025-08-01 |
| K251212 | 2025-07-01 |
| K243941 | 2025-01-17 |
| K213550 | 2022-05-04 |
| K193015 | 2020-02-20 |
| K172885 | 2018-02-20 |
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 |
|---|---|---|---|---|---|---|
| Access Vascular, Inc | 510(k) number | 2023-08-31 | Class II | Error in labeling | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is | 58 total |
| Access Vascular, Inc | 510(k) number | 2023-08-31 | Class II | Error in labeling | Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is | 58 total |
Recalls
2 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 | Closed |
|---|---|---|---|---|---|
| 2023-03-03 | Class II | Labeling mix-ups | The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. | 240 units | |
| 2021-02-24 | Class II | Process design | Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package. | 79 kits | 2024-05-30 |
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.