Infiniti
Multipack 5F Tempo ST.038 BL,PIG155,GW
11manufacturers in China registered for this device type
251catalogue numbers in this listing
29510(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 | Cordis Corp., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| 510(k) | K970854 |
| Record published | 2024-02-23 |
| Record revised | 2024-07-15 (version 8) |
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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 5, box of 10, box of 3, case of 5, box of 14 |
| Distribution end date | 2025-10-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SRD5074 | In distribution | ||
| 534693T | In distribution | ||
| 534645T | In distribution | ||
| CP0234 | In distribution | ||
| SRD5183 | In distribution | ||
| 534574T | In distribution | ||
| MODC18280 | In distribution | ||
| SRD5683 | In distribution | ||
| SRD7115 | In distribution | ||
| SRD7110 | In distribution | ||
| CP0210 | In distribution | ||
| SR4777 | In distribution | ||
| SRD6866 | In distribution | ||
| 534554S | In distribution | ||
| 538449 | In distribution | ||
| SRD6819 | In distribution | ||
| 538446 | In distribution | ||
| SRD6982 | In distribution | ||
| CP0436 | In distribution | ||
| SRD5827 | In distribution | ||
| 534650S | In distribution | ||
| IF4RBMP | In distribution | ||
| CP0173 | In distribution | ||
| CP0276 | In distribution | ||
| SRD5217 | In distribution | ||
| 538418 | In distribution | ||
| SRD5106 | In distribution | ||
| SRD7095 | In distribution | ||
| CP0437 | In distribution | ||
| 534578T | In distribution | ||
| SRD5327 | In distribution | ||
| 534644T | In distribution | ||
| CP0274 | In distribution | ||
| SRD7094 | In distribution | ||
| SRD6610 | In distribution | ||
| SRD7030 | In distribution | ||
| SRD5440 | In distribution | ||
| 534522T | In distribution | ||
| SRD6843 | In distribution | ||
| SRD5109 | In distribution | ||
| SR4780 | In distribution | ||
| 534552S | In distribution | ||
| 534525T | In distribution | ||
| 534541T | In distribution | ||
| 534572T | In distribution | ||
| SRD5141 | In distribution | ||
| SRD6791 | In distribution | ||
| 534518T | In distribution | ||
| 534642T | In distribution | ||
| 534629T | In distribution | ||
| SRD5126 | In distribution | ||
| CP0266 | In distribution | ||
| MODC18373 | In distribution | ||
| MODM18553 | In distribution | ||
| SRD6818 | In distribution | ||
| SRD6702 | In distribution | ||
| CP0427 | In distribution | ||
| SRD6984 | In distribution | ||
| SRD5737 | In distribution | ||
| SR4827 | 5 | In distribution | |
| 538499 | In distribution | ||
| SR4869 | In distribution | ||
| SRD7109 | In distribution | ||
| SRD7028 | In distribution | ||
| SRD5182 | In distribution | ||
| 534521T | In distribution | ||
| 538494 | In distribution | ||
| CP0222 | In distribution | ||
| CP0416 | In distribution | ||
| CP0282 | In distribution | ||
| SRD5428 | In distribution | ||
| 534650E | In distribution | ||
| CP0027 | In distribution | ||
| 538476 | In distribution | ||
| CP0066 | In distribution | ||
| SRD5055 | In distribution | ||
| 534531T | In distribution | ||
| SRD6001 | In distribution | ||
| MODC18405 | In distribution | ||
| 534680T | In distribution | ||
| CP0008 | In distribution | ||
| CP0171 | In distribution | ||
| SRD5189 | In distribution | ||
| CP0411 | In distribution | ||
| CP0208 | In distribution | ||
| SRD5674 | In distribution | ||
| SRD6080 | In distribution | ||
| SRD6601 | In distribution | ||
| CP0256 | In distribution | ||
| SRD7069 | In distribution | ||
| SRD7029 | In distribution | ||
| CP0281 | In distribution | ||
| CP0395 | In distribution | ||
| CP0206 | In distribution | ||
| CP0279 | In distribution | ||
| SRD6197 | In distribution | ||
| 534548T | In distribution | ||
| 534617T | In distribution | ||
| SRD6842 | In distribution | ||
| SR4878 | In distribution | ||
| 538498 | In distribution | ||
| 534692T | In distribution | ||
| SRD6728 | In distribution | ||
| CP0221 | In distribution | ||
| 534519T | In distribution | ||
| 534649T | In distribution | ||
| CP0018 | In distribution | ||
| 534562T | In distribution | ||
| SRD5352 | In distribution | ||
| SRD6692 | In distribution | ||
| 538444 | In distribution | ||
| SRD6771 | In distribution | ||
| SRD5286 | In distribution | ||
| SRD7041 | In distribution | ||
| MODC18283 | In distribution | ||
| SRD5505 | In distribution | ||
| 534595T | In distribution | ||
| 538460 | In distribution | ||
| SRD5886 | In distribution | ||
| CP0016 | In distribution | ||
| 534592T | In distribution | ||
| SRD6642 | In distribution | ||
| 534550E | In distribution | ||
| SRD6150 | In distribution | ||
| CP0441 | In distribution | ||
| SRD5042 | In distribution | ||
| CP0439 | In distribution | ||
| 534646T | In distribution | ||
| SRD5216 | In distribution | ||
| 534674T | In distribution | ||
| 534670T | In distribution | ||
| 534528T | In distribution | ||
| SRD6641 | In distribution | ||
| CP0418 | In distribution | ||
| CP0258 | In distribution | ||
| MODC18314 | In distribution | ||
| SRD6638 | In distribution | ||
| 534527T | In distribution | ||
| MODC18284 | In distribution | ||
| SRD6724 | In distribution | ||
| MODC18821 | In distribution | ||
| SRD6609 | In distribution | ||
| 534545T | In distribution | ||
| SRD6899 | In distribution | ||
| 534517T | In distribution | ||
| 534570T | In distribution | ||
| CP0097 | In distribution | ||
| SRD5908 | In distribution | ||
| 534549T | In distribution | ||
| 538451V | In distribution | ||
| CP0302 | In distribution | ||
| MODC18282 | In distribution | ||
| CP0242 | In distribution | ||
| SRD5554 | In distribution | ||
| MODM18072 | In distribution | ||
| SRD5406 | In distribution | ||
| SRD5441 | In distribution | ||
| 534547T | In distribution | ||
| 534643T | In distribution | ||
| SRD5259 | In distribution | ||
| MODM18882 | In distribution | ||
| SRD6952 | In distribution | ||
| SRD5263 | In distribution | ||
| CP0421 | In distribution | ||
| CP0125 | In distribution | ||
| SRD6472 | In distribution | ||
| SRD6918 | In distribution | ||
| SRD6545 | In distribution | ||
| 538431 | In distribution | ||
| SRD5199 | In distribution | ||
| SRD5332 | In distribution | ||
| CP0243 | In distribution | ||
| CP0203 | In distribution | ||
| SRD6961 | In distribution | ||
| SRD7033 | In distribution | ||
| SRD5066 | In distribution | ||
| MODC17638 | In distribution | ||
| SRD5036 | In distribution | ||
| CP0241 | In distribution | ||
| SR4980 | In distribution | ||
| 538474 | In distribution | ||
| 538424 | In distribution | ||
| 534589T | In distribution | ||
| SRD5514 | In distribution | ||
| SRD6944 | In distribution | ||
| SRD5930 | In distribution | ||
| SR4930 | In distribution | ||
| MODC18498 | In distribution | ||
| 538493 | In distribution | ||
| SRD7018 | In distribution | ||
| SRD6844 | In distribution | ||
| 534593T | In distribution | ||
| SRD6865 | In distribution | ||
| 534543T | In distribution | ||
| 534553S | In distribution | ||
| SRD5469 | In distribution | ||
| CP0150 | In distribution | ||
| SRD7099 | In distribution | ||
| MODM17422 | In distribution | ||
| 534614T | In distribution | ||
| SRD6716 | In distribution | ||
| SRD6942 | In distribution | ||
| SRD5825 | In distribution | ||
| SRD6018 | In distribution | ||
| CP0152 | In distribution | ||
| 534560T | In distribution | ||
| CP0409 | In distribution | ||
| SRD5679 | In distribution | ||
| 534672T | In distribution | ||
| SRD5826 | In distribution | ||
| SRD6092 | In distribution | ||
| CP0404 | In distribution | ||
| MODM17629 | In distribution | ||
| SRD6691 | In distribution | ||
| 534539T | In distribution | ||
| SRD5808 | In distribution | ||
| SRD6000 | In distribution | ||
| SRD5396 | In distribution | ||
| SRD6773 | In distribution | ||
| SRD6611 | In distribution | ||
| SRD7111 | In distribution | ||
| SRD5680 | In distribution | ||
| SRD6670 | In distribution | ||
| CP0257 | In distribution | ||
| CP0207 | In distribution | ||
| CP0092 | In distribution | ||
| CP0088 | In distribution | ||
| 534550S | In distribution | ||
| SRD7057 | In distribution | ||
| 538453S | In distribution | ||
| SRD7017 | 5 | In distribution | |
| CP0269 | Withdrawn | ||
| CP0319 | Withdrawn | ||
| 555625R451 | Withdrawn | ||
| 534529T | Withdrawn | ||
| 555600R451 | Withdrawn | ||
| SRD7073 | Withdrawn | ||
| MODC17991 | Withdrawn | ||
| 555625J2 | Withdrawn | ||
| 555500R451 | Withdrawn | ||
| 555500R351 | Withdrawn | ||
| 555500R501 | Withdrawn | ||
| 555625R351 | Withdrawn | ||
| 555600R401 | Withdrawn | ||
| 555625R401 | Withdrawn | ||
| 555625T1 | Withdrawn | ||
| 555525R451 | Withdrawn | ||
| 555600R351 | Withdrawn | ||
| 555525J2 | Withdrawn | ||
| 555525R501 | Withdrawn |
Showing 250 of 251 catalogue numbers.
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 US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
| Expo™ | Boston Scientific Corporation | 180 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212977 | 2022-02-17 |
| K020316 | 2002-03-20 |
| K000579 | 2000-05-03 |
| K992347 | 1999-10-08 |
| K991673 | 1999-05-26 |
| K973401 | 1997-11-18 |
| K970854 | 1997-09-30 |
| K971646 | 1997-07-14 |
| K962759 | 1996-10-10 |
| K960975 | 1996-04-02 |
| K942939 | 1994-08-31 |
| K936260 | 1994-05-31 |
| K922891 | 1993-06-23 |
| K930479 | 1993-04-21 |
| K921310 | 1992-09-17 |
| K915498 | 1992-04-17 |
| K915836 | 1992-02-11 |
| K914141 | 1991-10-23 |
| K914007 | 1991-10-18 |
| K911703 | 1991-06-28 |
| K905297 | 1991-02-01 |
| K896308 | 1990-03-28 |
| K872248 | 1987-08-12 |
| K864141 | 1986-11-03 |
| K862244 | 1986-08-25 |
| K862006 | 1986-06-27 |
| K854576 | 1986-02-26 |
| K844161 | 1985-01-02 |
| K802629 | 1980-10-31 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2023-09-26 | Class I | Process control | Non-sterile product labeled as sterile was distributed. | 30 devices | |
| Cordis US Corp. | 510(k) number | 2022-11-07 | Class II | Under Investigation by firm | There is a potential for separation at the male connector. | 16,950 units (2,915 US and 14,000 OUS) | |
| Cordis US Corp. | 510(k) number | 2006-06-26 | Not classified | Other | The tip of the catheter may separate from the body during operation. | 338,270 | 2008-11-19 |
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.