Supercath 5
46 catalogue numbers from SP120-20-25-WT, listed by Togo Medikit Co., Ltd., Japan, under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
46catalogue 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 | Togo Medikit Co., Ltd., Japan |
|---|---|
| FDA product code | FOZ |
| Device type | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-04-24 |
| Record revised | 2024-04-15 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 60 to 80 °F; Storage environment humidity up to 75 % RH; Special storage condition: Store in a dry, dark, room-temperature cabinet or closet. |
| Packaging | Box of 50, carton of 4, carton of 20 |
| Distribution end date | 2018-01-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP120-20-25-WT | In distribution | |
| SP120-22-25-WT | In distribution | |
| SP125-22-25-WT | 0.7mm Catheter Diameter | In distribution |
| SP120-16-31-WT | In distribution | |
| SP120-16-31T | In distribution | |
| SP125-22-25T | In distribution | |
| SP120-22-25T | In distribution | |
| SP120-20-25T | In distribution | |
| SP120-22-31T | In distribution | |
| SP120-20-50T | In distribution | |
| SP125-16-31-WT | In distribution | |
| SP125-22-25T | In distribution | |
| SP125-14-31-WT | In distribution | |
| SP120-20-50-WT | In distribution | |
| SP125-24-19T | In distribution | |
| SP125-26-14-WT | In distribution | |
| SP125-26-19-WT | In distribution | |
| SP120-18-50-WT | In distribution | |
| SP125-16-31T | In distribution | |
| SP120-24-19T | In distribution | |
| SP120-20-31-WT | In distribution | |
| SP125-24-14T | In distribution | |
| SP125-14-31T | In distribution | |
| SP125-26-19-WT | In distribution | |
| SP120-20-31T | In distribution | |
| SP125-26-19T | In distribution | |
| SP120-22-31-WT | In distribution | |
| SP120-18-31-WT | In distribution | |
| SP120-24-19-WT | In distribution | |
| SP120-18-31T | In distribution | |
| SP125-26-14-WT | In distribution | |
| SP120-18-50T | In distribution | |
| SP205-01 | 31 mm Catheter Length | Withdrawn |
| SP208-01 | 0.7mm Catheter Diameter | Withdrawn |
| SP207-01 | 1.1mm Catheter Diameter | Withdrawn |
| SP210-01 | 31 mm Catheter Length | Withdrawn |
| SP212-01 | 2.1mm Catheter Diameter | Withdrawn |
| SP200-01 | 25 mm Catheter Length | Withdrawn |
| SP213-01 | 31 mm Catheter Length | Withdrawn |
| SP209-01 | 0.7mm Catheter Diameter | Withdrawn |
| SP206-01 | 31 mm Catheter Length | Withdrawn |
| SP202-01 | 31 mm Catheter Length | Withdrawn |
| SP201-01 | 25 mm Catheter Length | Withdrawn |
| SP204-01 | 1.3mm Catheter Diameter | Withdrawn |
| SP203-01 | 0.9mm Catheter Diameter | Withdrawn |
| SP211-01 | 31 mm Catheter Length | Withdrawn |
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 |
|---|---|
| K190001 | 2019-09-20 |
| K172496 | 2018-03-23 |
| K160592 | 2016-08-12 |
| K140419 | 2014-05-12 |
| K112290 | 2012-04-16 |
| K093546 | 2009-12-17 |
| K081953 | 2009-03-12 |
| K050114 | 2005-06-09 |
| K864038 | 1986-12-04 |
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.