Deltaven
Safety I.V Catheter in PUR with closed system , Y final adapter and 2 detachable needle less valve
12manufacturers in China registered for this device type
73catalogue numbers in this listing
3510(k) clearances naming this product code
11recalls on this 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 | Delta Med SpA, Italy |
|---|---|
| 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 | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2018-01-19 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Packaging | Box of 4, case of 25, case of 20 |
| Sizes | Outer diameter 0.64 to 1.75 mm; length 19 to 45 mm; length 19 to 32 µm; height 32 to 45 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3841072 | Gauge 18 | In distribution |
| 3841172 | Outer Diameter 1.3 mm | In distribution |
| 3821072 | Gauge 22 | In distribution |
| 3845472 | Gauge 18 | In distribution |
| 3836372 | Gauge 20 | In distribution |
| 3831172 | Gauge 20 | In distribution |
| 3833572 | Gauge 20 | In distribution |
| 3852572 | Gauge 16 | In distribution |
| 3823072 | Gauge 22 | In distribution |
| 3833172 | Gauge 20 | In distribution |
| 3824472 | Gauge 22 | In distribution |
| 3847372 | Gauge 18 | In distribution |
| 3822572 | Gauge 22 | In distribution |
| 3811072 | Gauge 24 | In distribution |
| 3832572 | Gauge 20 | In distribution |
| 3835372 | Gauge 20 | In distribution |
| 3832172 | Gauge 20 | In distribution |
| 3814372 | Gauge 24 | In distribution |
| 3841572 | Gauge 18 | In distribution |
| 3831572 | Gauge 20 | In distribution |
| 3831072 | Gauge 20 | In distribution |
| 3843572 | Gauge 18 | In distribution |
| 3837372 | Gauge 20 | In distribution |
| 3821172 | Gauge 22 | In distribution |
| 3814472 | Gauge 24 | In distribution |
| 3846472 | Outer Diameter 1.3 mm | In distribution |
| 3852172 | Gauge 16 | In distribution |
| 3852072 | Gauge 16 | In distribution |
| 3847272 | Gauge 18 | In distribution |
| 3837472 | Outer Diameter 1.00 mm | In distribution |
| 3810172 | Gauge 24 | In distribution |
| 3835472 | Gauge 20 | In distribution |
| 3843072 | Gauge 18 | In distribution |
| 3836472 | Gauge 20 | In distribution |
| 3845372 | Gauge 18 | In distribution |
| 3804472 | Gauge 26 | In distribution |
| 3842572 | Gauge 18 | In distribution |
| 3800072 | Outer Diameter 0.64 mm | In distribution |
| 3810572 | Gauge 24 | In distribution |
| 3856372 | Gauge 16 | In distribution |
| 3826472 | Gauge 20 | In distribution |
| 3820172 | Gauge 22 | In distribution |
| 3846372 | Gauge 18 | In distribution |
| 3820072 | Gauge 22 | In distribution |
| 3821572 | Gauge 22 | In distribution |
| 3835272 | Gauge 20 | In distribution |
| 3822072 | Gauge 22 | In distribution |
| 3825472 | Gauge 22 | In distribution |
| 3800572 | Gauge 26 | In distribution |
| 3810072 | Outer Diameter 0.74 mm | In distribution |
| 3837272 | Gauge 20 | In distribution |
| 3825272 | Gauge 22 | In distribution |
| 3836272 | Gauge 20 | In distribution |
| 3824372 | Gauge 22 | In distribution |
| 3842172 | Gauge 18 | In distribution |
| 3856472 | Gauge 16 | In distribution |
| 3826372 | Gauge 22 | In distribution |
| 3804272 | Gauge 26 | In distribution |
| 3842072 | GAUGE 18 | In distribution |
| 3825372 | Gauge 22 | In distribution |
| 3846272 | Gauge 18 | In distribution |
| 3814272 | Gauge 24 | In distribution |
| 3832072 | Gauge 20 | In distribution |
| 3826272 | Gauge 22 | In distribution |
| 3845272 | Gauge 18 | In distribution |
| 3800172 | Outer Diameter 0.64 mm | In distribution |
| 3843172 | Gauge 18 | In distribution |
| 3824272 | Gauge 22 | In distribution |
| 3820572 | Gauge 22 | In distribution |
| 3833072 | Gauge 20 | In distribution |
| 3856272 | Gauge 16 | In distribution |
| 3847472 | Gauge 18 | In distribution |
| 3804372 | Gauge 26 | 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 |
| 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 |
| Cragg-McNamaraTM | Micro Therapeutics, Inc. | 57 |
Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200373 | 2020-08-26 |
| K171530 | 2017-12-21 |
| K121007 | 2012-12-28 |
Recalls
11 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 |
|---|---|---|---|---|
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 20,000 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 30,900 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 14,000 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 203,680 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 40,000 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 1400 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 229,320 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 5000 units |
| 2021-06-21 | Class II | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | 10,000 units |
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.