DeRoyal
TD Catheter 7FR,4 Lumen,Hep Coated Safety Wedge
11manufacturers in China registered for this device type
153catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (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 |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-06-22 |
| Record revised | 2021-08-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, case of 400, case of 5, case of 80, box of 5, case of 200 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301656A-AM | In distribution | |
| DTD1702HX5 | In distribution | |
| 301655A | In distribution | |
| 77-400213 | In distribution | |
| DTD1704HDX5 | In distribution | |
| DTD1604HX | In distribution | |
| 77-401003 | In distribution | |
| 301660A | In distribution | |
| 301211A | In distribution | |
| 301224A | In distribution | |
| 301210C | In distribution | |
| 35-300691 | In distribution | |
| 301220B | In distribution | |
| 301229A | In distribution | |
| 301652B | In distribution | |
| 301230B | In distribution | |
| 77-400603 | In distribution | |
| 35-530045 | In distribution | |
| 77-530142 | In distribution | |
| 77-301602 | In distribution | |
| 301657BIO | In distribution | |
| 77-300783 | In distribution | |
| 35-401215 | In distribution | |
| 301659A | In distribution | |
| 77-401016 | In distribution | |
| DTD1704HCX5 | In distribution | |
| 301651A | In distribution | |
| 301652A-AM | In distribution | |
| DTD1504HX5 | In distribution | |
| 77-530150 | In distribution | |
| 77-400985 | In distribution | |
| 77-300772 | In distribution | |
| 301226A | In distribution | |
| DTD1704HX5 | In distribution | |
| 301230A | In distribution | |
| 77-400169 | In distribution | |
| 77-300725 | In distribution | |
| 77-400315 | In distribution | |
| 301216A | In distribution | |
| 77-300735 | In distribution | |
| DTD1755HDPX | In distribution | |
| 301657B | In distribution | |
| 77-530141 | In distribution | |
| 77-400900 | In distribution | |
| 301657A | In distribution | |
| 301210B | In distribution | |
| 77-530152 | In distribution | |
| 301655A-AM | In distribution | |
| 77-400192 | In distribution | |
| 77-301607 | In distribution | |
| 301210A | In distribution | |
| 301654B | In distribution | |
| 301205A | In distribution | |
| 77-530145 | In distribution | |
| 301655B | In distribution | |
| 35-401056 | In distribution | |
| DTD1502HX5 | In distribution | |
| 35-300772 | In distribution | |
| DTD1604HDX5 | In distribution | |
| 77-300726 | In distribution | |
| 77-400372 | In distribution | |
| 77-530149 | In distribution | |
| 35-401092 | In distribution | |
| 301225A | In distribution | |
| 77-400839 | In distribution | |
| 301658B | In distribution | |
| 301228A | In distribution | |
| 301658 | In distribution | |
| 77-400604 | In distribution | |
| 77-400369 | In distribution | |
| 301230BIO | In distribution | |
| 77-300691 | In distribution | |
| DTD1603HX5 | In distribution | |
| 301225B | In distribution | |
| 77-400376 | In distribution | |
| 77-301600 | In distribution | |
| 35-400215-V | In distribution | |
| 301212A | In distribution | |
| 77-530148 | In distribution | |
| 77-400215 | In distribution | |
| 301201A | In distribution | |
| 35-300692 | In distribution | |
| 77-530143 | In distribution | |
| 301658A | In distribution | |
| DCL1702HX | In distribution | |
| 77-400206 | In distribution | |
| DTD1602HX | In distribution | |
| 301652A | In distribution | |
| 35-300735 | In distribution | |
| 77-301606 | In distribution | |
| DTD1702HX | In distribution | |
| 77-400775 | In distribution | |
| 301205B | In distribution | |
| 301225BIO | In distribution | |
| 35-289898 | In distribution | |
| DTD1704HCX | In distribution | |
| 35-300736 | In distribution | |
| 301205C | In distribution | |
| DCL1702HX5 | In distribution | |
| 301661A | In distribution | |
| 77-300696 | In distribution | |
| 77-300752 | In distribution | |
| 35-301735 | In distribution | |
| DTD1604HX5 | In distribution | |
| 77-401018 | In distribution | |
| 301220A | In distribution | |
| 77-300695 | In distribution | |
| 77-301601 | In distribution | |
| DTD1704HX | In distribution | |
| 77-400234 | In distribution | |
| 35-301725 | In distribution | |
| 77-400229 | In distribution | |
| 77-400371 | In distribution | |
| 35-314952 | In distribution | |
| 35-401050 | In distribution | |
| 77-400377 | In distribution | |
| DTD1603HX | In distribution | |
| 77-301603 | In distribution | |
| 301656B | In distribution | |
| 77-300692 | In distribution | |
| 301653A | In distribution | |
| 77-8837 | In distribution | |
| 77-301605 | In distribution | |
| 77-300692V | In distribution | |
| 301120A | In distribution | |
| 301215A | In distribution | |
| 35-400846 | In distribution | |
| 35-400215 | In distribution | |
| DTD1502HX | In distribution | |
| 301220C | In distribution | |
| 77-400235 | In distribution | |
| 35-300695 | In distribution | |
| 77-400407 | In distribution | |
| DTD1755HDPX5 | In distribution | |
| 301215B | In distribution | |
| 301231A | In distribution | |
| 77-400606 | In distribution | |
| 35-301042 | In distribution | |
| DTD1703HX5 | In distribution | |
| 35-400584 | In distribution | |
| 35-301691 | In distribution | |
| DTD1755HX5 | In distribution | |
| 301227A | In distribution | |
| 77-400744 | In distribution | |
| 35-300783 | In distribution | |
| DTD1504HDX5 | In distribution | |
| 301656A | In distribution | |
| 35-301692 | In distribution | |
| DTD1755HDX5 | In distribution | |
| DTD1602HX5 | In distribution | |
| 77-301604 | In distribution | |
| 77-400370 | In distribution | |
| 301654A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023591 | 2003-06-18 |
| K935985 | 1994-12-21 |
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.