Thermodilution Catheter and Accessories
49 catalogue numbers from TD1755HD, listed by Bioptimal International Pte. Ltd., Singapore, under Catheter, Intravascular, Diagnostic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
49catalogue numbers in this listing
1510(k) clearance
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 | Bioptimal International Pte. Ltd., Singapore |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Manufacturer |
| Record published | 2026-05-20 |
| Record revised | 2023-12-04 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark cool dry places |
| Packaging | Carton of 30, box of 5, carton of 6, cyn of 6, carton of 9, pulk pack of 50 |
| Distribution end date | 2024-05-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TD1755HD | In distribution | |
| TD2504NXF | In distribution | |
| TD1755ND-ARG(497520) | In distribution | |
| TD2755NDX | In distribution | |
| TD2755NXF-MERIT(EUROPE) | In distribution | |
| TD1755NSD-ARG(497531) | In distribution | |
| TD1604ND-ARG(497537) | In distribution | |
| TD2755NDF | In distribution | |
| TD2504NDXF | In distribution | |
| TD2755NDFX-BSI | In distribution | |
| TD2704NFX (BNS) – CMS USA | In distribution | |
| TD1704NXC-ARG(497536) | In distribution | |
| TD2704NXF-BSI | In distribution | |
| TD2755NX | In distribution | |
| TD2704NCFX-BSI | In distribution | |
| TD1604ND-ARG(497537) | In distribution | |
| TD1704NX-ARG(497526) | In distribution | |
| TD2755NX-CCF | In distribution | |
| TD2704NXF-BSI | In distribution | |
| TD2604NDXF | In distribution | |
| TD2604NXF | In distribution | |
| TD2704NXF-MERIT(EUROPE) | In distribution | |
| TD2755NDPXF | In distribution | |
| TD2755NDF | In distribution | |
| TD2704NDF | In distribution | |
| TD1704NDX-ARG(497539) | In distribution | |
| TD2704NCXF | In distribution | |
| TD2704NCFX-BSI | In distribution | |
| TD1704NDC-ARG(497534) | In distribution | |
| TD1704ND-ARG(497521) | In distribution | |
| TD2604NX (BNS)-CMS USA | In distribution | |
| TD1702NX-ARG(497523) | Withdrawn | |
| TD1704NXC-ARG(497536) | Withdrawn | |
| CL1702NX-ARG(497540) | Withdrawn | |
| TD1704NX-ARG(497526) | Withdrawn | |
| TD1704ND-ARG(497521) | Withdrawn | |
| TD1702NX-ARG(497523) | Withdrawn | |
| TD1755NSD-ARG(497531) | Withdrawn | |
| TD1755ND-ARG(497520) | Withdrawn | |
| CL1702NX-ARG(497540) | Withdrawn | |
| TD1704NDC-ARG(497534) | Withdrawn | |
| TD1602NX-ARG(497527) | Withdrawn | |
| TD2602NXF-MERIT(EUROPE) | Withdrawn | |
| TD2755NDFX-BSI | Withdrawn | |
| TD2755NX-CCF | Withdrawn | |
| TD2604NX (BNS)-CMS USA | Withdrawn | |
| TD1602NX-ARG(497527) | Withdrawn | |
| TD1704NDX-ARG(497539) | Withdrawn | |
| TD2704NFX (BNS) – CMS USA | Withdrawn |
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 |
|---|---|
| K252702 | 2026-05-28 |
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.