DeRoyal
Cardiovascular Inst of Central FL Basic Cardiac Cath Kit
15manufacturers in China registered for this device type
138catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | Fuzhou | Jiangxi | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shandong INT Medical Instruments Co., Ltd. | Rizhao | Shandong | Manufacturer | 4 |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2023-04-12 (version 3) |
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 | Case of 25, case of 100, case of 20, case of 50, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77-400943 | In distribution | |
| SY-1253A | In distribution | |
| 35-401080 | In distribution | |
| SY-1014-AM | In distribution | |
| 77-150269 | In distribution | |
| SY-1071A | In distribution | |
| 35-401009 | In distribution | |
| SY-1053A | In distribution | |
| 77-400887 | In distribution | |
| 77-400508 | In distribution | |
| 77-401026 | In distribution | |
| 77-400536 | In distribution | |
| SY-1231VS | In distribution | |
| 77-400824 | In distribution | |
| 77-400988 | In distribution | |
| 79-401104 | In distribution | |
| 35-401077 | In distribution | |
| 35-401094 | In distribution | |
| 12-000249 | In distribution | |
| SY-1217 | In distribution | |
| 77-400977 | In distribution | |
| 77-400869 | In distribution | |
| 77-401036 | In distribution | |
| 77-300741 | In distribution | |
| 35-401079 | In distribution | |
| SY-0831 | In distribution | |
| 77-400941 | In distribution | |
| 77-401008 | In distribution | |
| SY-1211A | In distribution | |
| 35-401069 | In distribution | |
| 77-400981 | In distribution | |
| 79-401038 | In distribution | |
| 77-400523 | In distribution | |
| 35-401064 | In distribution | |
| 77-400907 | In distribution | |
| 77-400456 | In distribution | |
| SY-1231 | In distribution | |
| SY-1245 | In distribution | |
| 77-400522 | In distribution | |
| 77-400330 | In distribution | |
| 79-401108 | In distribution | |
| 35-401078 | In distribution | |
| SY-1214-AM | In distribution | |
| 77-401037 | In distribution | |
| 77-301294 | In distribution | |
| 77-311112 | In distribution | |
| SY-1018 | In distribution | |
| 77-400534 | In distribution | |
| 79-401061 | In distribution | |
| SY-1024 | In distribution | |
| 35-400860 | In distribution | |
| 77-401090 | In distribution | |
| 35-401105 | In distribution | |
| 77-400978 | In distribution | |
| 77-301293 | In distribution | |
| SY-1051 | In distribution | |
| SY-1024-AM | In distribution | |
| SY-1011A | In distribution | |
| 77-400548 | In distribution | |
| 77-400890 | In distribution | |
| 77-400589 | In distribution | |
| 35-401068 | In distribution | |
| 77-400250 | In distribution | |
| 77-401012 | In distribution | |
| 77-401020 | In distribution | |
| 35-401072 | In distribution | |
| 77-131112 | In distribution | |
| 35-401058 | In distribution | |
| 77-400742 | In distribution | |
| 77-401106 | In distribution | |
| SY-1214 | In distribution | |
| 77-400694 | In distribution | |
| 35-400972 | In distribution | |
| 77-400812 | In distribution | |
| 77-401007 | In distribution | |
| 35-401071 | In distribution | |
| 77-301291 | In distribution | |
| 35-401075 | In distribution | |
| 77-400293 | In distribution | |
| 77-401013 | In distribution | |
| 77-401028 | In distribution | |
| 77-401019 | In distribution | |
| 77-401015 | In distribution | |
| 77-300743 | In distribution | |
| 77-400965 | In distribution | |
| 77-301292 | In distribution | |
| 77-401111 | In distribution | |
| 77-400892 | In distribution | |
| 77-401014 | In distribution | |
| 77-400737 | In distribution | |
| 77-400796 | In distribution | |
| 77-401035 | In distribution | |
| 35-401054 | In distribution | |
| 77-400708 | In distribution | |
| 77-400476 | In distribution | |
| 35-400876 | In distribution | |
| 77-400980 | In distribution | |
| 77-200590 | In distribution | |
| 77-400220 | In distribution | |
| 79-401024 | In distribution | |
| 77-400863 | In distribution | |
| SY-1243A | In distribution | |
| 77-400649 | In distribution | |
| SY-1014 | In distribution | |
| 79-401109 | In distribution | |
| 77-400944 | In distribution | |
| 77-400987 | In distribution | |
| 35-401070 | In distribution | |
| 77-401059 | In distribution | |
| 35-401067 | In distribution | |
| 77-400955 | In distribution | |
| 77-300744 | In distribution | |
| 79-401041 | In distribution | |
| 77-400527 | In distribution | |
| 77-301301 | In distribution | |
| 77-400808 | In distribution | |
| SY-1031 | In distribution | |
| 77-400936 | In distribution | |
| SY-1231CMC | In distribution | |
| 77-400866 | In distribution | |
| 77-400919 | In distribution | |
| SY-1251CMC | In distribution | |
| 77-400711 | In distribution | |
| 77-400454 | In distribution | |
| 77-400743 | In distribution | |
| 77-712391-5 | In distribution | |
| 77-401034 | In distribution | |
| 77-400939 | In distribution | |
| 77-400575 | In distribution | |
| 77-400574 | In distribution | |
| 77-300742 | In distribution | |
| 77-400942 | In distribution | |
| 77-400997 | In distribution | |
| SY-1251 | In distribution | |
| 77-400277 | In distribution | |
| 77-301304 | In distribution | |
| 77-331112 | In distribution | |
| 77-712391 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | Shenzhen Boon Medical Supply Co., Ltd. | 199 |
| Antmed | Shenzhen Antmed Co., Ltd. | 91 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| LF | Liebel-Flarsheim Company LLC | 58 |
| Namic | Medline Industries, Inc. | 50 |
| Merit Medical® | Merit Medical Systems, Inc. | 46 |
| Medical Imaging Solutions International | Shenzhen Boon Medical Supply Co., Ltd. | 43 |
| LF | Shenzhen Boon Medical Supply Co., Ltd. | 38 |
| Namic | Navilyst Medical, Inc. | 38 |
| Coeur | Coeur, Inc. | 38 |
| Medical Imaging Solutions Intl. | Medical Imaging Solutions, Inc. | 37 |
| CVi® Cable | Acist Medical Systems, Inc. | 30 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152978 | 2016-03-25 |
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.