Pro-Flo XT™
Cath 009234 PF 10PK 6F XT ST NO Torque R
11manufacturers in China registered for this device type
62catalogue numbers in this listing
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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K960056 |
| Record published | 2016-06-13 |
| Record revised | 2022-09-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store catheters in a cool, dry area. |
| Packaging | Pack of 10, pack of 5 |
| Sizes | Length 100 to 125 cm; lumen/inner diameter 1.27 to 1.55 mm; catheter gauge 6 to 7 Fr |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010352 | Length 100.0 cm | In distribution |
| 010351 | Catheter Gauge 6.0 Fr | In distribution |
| 010348 | Length 100.0 cm | In distribution |
| 010342 | Length 110.0 cm | In distribution |
| 009234 | Catheter Gauge 6.0 Fr | In distribution |
| 010243 | Length 110.0 cm | In distribution |
| 010371 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010354 | Catheter Gauge 6.0 Fr | In distribution |
| 010343 | Length 100.0 cm | In distribution |
| 010346 | Length 100.0 cm | In distribution |
| 010344 | Catheter Gauge 6.0 Fr | In distribution |
| 010350 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010365 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010353 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 060048 | Catheter Gauge 6.0 Fr | In distribution |
| 010341 | Catheter Gauge 6.0 Fr | In distribution |
| 010321 | Length 110.0 cm | In distribution |
| 010356 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010340 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 060033 | Catheter Gauge 6.0 Fr | In distribution |
| 010373 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010364 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010345 | Length 100.0 cm | In distribution |
| 060019 | Length 110.0 cm | In distribution |
| 010242 | Catheter Gauge 6.0 Fr | In distribution |
| 010212 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010372 | Length 100.0 cm | In distribution |
| 010052 | Lumen/Inner Diameter 1.55 mm | In distribution |
| 010241 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 060038 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010244 | Length 110.0 cm | In distribution |
| 010355 | Catheter Gauge 7.0 Fr | In distribution |
| 010319 | Catheter Gauge 6.0 Fr | In distribution |
| 010349 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010161 | Catheter Gauge 6.0 Fr | In distribution |
| 009231 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010347 | Lumen/Inner Diameter 1.27 mm | In distribution |
| 010160 | Catheter Gauge 6.0 Fr | In distribution |
| 010366 | Length 100.0 cm | In distribution |
| 010318 | Length 100.0 cm | In distribution |
| 060051 | Catheter Gauge 6.0 Fr | Withdrawn |
| 010162 | Length 100.0 cm | Withdrawn |
| 010363 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010247 | Length 100.0 cm | Withdrawn |
| 010248 | Catheter Gauge 7.0 Fr | Withdrawn |
| 010361 | Catheter Gauge 7.0 Fr | Withdrawn |
| 060036 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010358 | Length 110.0 cm | Withdrawn |
| 010320 | Lumen/Inner Diameter 1.27 mm | Withdrawn |
| 060049 | Catheter Gauge 6.0 Fr | Withdrawn |
| 010368 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010370 | Length 100.0 cm | Withdrawn |
| 010359 | Catheter Gauge 7.0 Fr | Withdrawn |
| 010362 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010367 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010163 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 06PX008 | Length 110.0 cm | Withdrawn |
| 06PX011 | Length 110.0 cm | Withdrawn |
| 010369 | Lumen/Inner Diameter 1.55 mm | Withdrawn |
| 010214 | Lumen/Inner Diameter 1.27 mm | Withdrawn |
| 010360 | Length 100.0 cm | Withdrawn |
| 009235 | Catheter Gauge 7.0 Fr | 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
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.