Deltaven Fast Flash
Safety IV catheter in PUR with closed system, single entry with stopcock and needleless valve
12manufacturers in China registered for this device type
77catalogue 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 | 2020-10-26 |
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, box of 5, case of 4 |
| Sizes | Outer diameter 0.64 to 1.75 mm; length 19 to 45 mm; catheter length 32 to 45 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3843573 | Outer Diameter 1.30 mm | In distribution |
| 3856873 | Length 32 mm | In distribution |
| 3804373 | Outer Diameter 0.64 mm | In distribution |
| 3811073 | Outer Diameter 0.74 mm | In distribution |
| 3836373 | Outer Diameter 1.00 mm | In distribution |
| 3825973 | Length 25 mm | In distribution |
| 3852673 | Length 32 mm | In distribution |
| 3842673 | Length 32 mm | In distribution |
| 3825373 | Outer Diameter 0.90 mm | In distribution |
| 3835373 | Outer Diameter 1.00 mm | In distribution |
| 3845973 | Length 25 mm | In distribution |
| 3836873 | Length 32 mm | In distribution |
| 3837773 | Length 45 mm | In distribution |
| 3837973 | Length 45 mm | In distribution |
| 3821673 | 22 gauge | In distribution |
| 3837373 | Outer Diameter 1.00 mm | In distribution |
| 3814973 | Length 19 mm | In distribution |
| 3842573 | Outer Diameter 1.30 mm | In distribution |
| 3843473 | Length 45 mm | In distribution |
| 3846773 | Length 32 mm | In distribution |
| 3845373 | Outer Diameter 1.30 mm | In distribution |
| 3824873 | Length 19 mm | In distribution |
| 3821473 | Length 25 mm | In distribution |
| 3856373 | Outer Diameter 1.75 mm | In distribution |
| 3833573 | Outer Diameter 1.00 mm | In distribution |
| 3800673 | Outer Diameter 0.64 mm | In distribution |
| 3832573 | Outer Diameter 1.00 mm | In distribution |
| 3821573 | Outer Diameter 0.90 mm | In distribution |
| 3825773 | Length 25 mm | In distribution |
| 3852473 | Length 32 mm | In distribution |
| 3836973 | Length 25 mm | In distribution |
| 3820573 | Outer Diameter 0.90 mm | In distribution |
| 3841573 | Outer Diameter 1.00 mm | In distribution |
| 3846973 | Length 32 mm | In distribution |
| 3832673 | Outer Diameter 1.00 mm | In distribution |
| 3852573 | Outer Diameter 1.75 mm | In distribution |
| 3831573 | Outer Diameter 1.00 mm | In distribution |
| 3824773 | Length 19 mm | In distribution |
| 3820473 | Length 19 mm | In distribution |
| 3804873 | Length 19 mm | In distribution |
| 3825873 | Length 25 mm | In distribution |
| 3845873 | Length 25 mm | In distribution |
| 3804973 | Length 19 mm | In distribution |
| 3831473 | Length 25 mm | In distribution |
| 3841673 | Length 25 mm | In distribution |
| 3833673 | Outer Diameter 1.00 mm | In distribution |
| 3847973 | Length 45 mm | In distribution |
| 3835873 | Length 25 mm | In distribution |
| 3837873 | Length 45 mm | In distribution |
| 3814373 | Outer Diameter 0.74 mm | In distribution |
| 3856773 | Length 32 mm | In distribution |
| 3800473 | Length 19 mm | In distribution |
| 3811473 | Length 19 mm | In distribution |
| 3841473 | Length 25 mm | In distribution |
| 3847373 | Outer Diameter 1.30 mm | In distribution |
| 3810673 | Length 19 mm | In distribution |
| 3814873 | Length 19 mm | In distribution |
| 3804773 | Length 19 mm | In distribution |
| 3847773 | Length 45 mm | In distribution |
| 3842473 | Length 32 mm | In distribution |
| 3832473 | Length 32 mm | In distribution |
| 3824973 | Length 19 mm | In distribution |
| 3843673 | Length 45 mm | In distribution |
| 3845773 | Length 25 mm | In distribution |
| 3824373 | Outer Diameter 0.90 mm | In distribution |
| 3831673 | Outer Diameter 1.00 mm | In distribution |
| 3846873 | Length 32 mm | In distribution |
| 3836773 | Length 32 mm | In distribution |
| 3820673 | 22 Gauge | In distribution |
| 3835973 | Length 25 mm | In distribution |
| 3856973 | Length 32 mm | In distribution |
| 3835773 | Length 25 mm | In distribution |
| 3833473 | Length 45 mm | In distribution |
| 3800573 | Outer Diameter 0.64 mm | In distribution |
| 3814773 | Length 19 mm | In distribution |
| 3846373 | Outer Diameter 1.30 mm | In distribution |
| 3847873 | Length 45 mm | 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 | 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 |
| 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.