Heartrail
HEARTRAIL III Guiding Catheter
11manufacturers in China registered for this device type
65catalogue numbers in this listing
9510(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 | Terumo Corp., Japan |
|---|---|
| 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, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2021-12-22 (version 6) |
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, expiry date |
| Storage | Special storage condition: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10. |
| Packaging | Carton of 5 |
| Sizes | Lumen/inner diameter 1.47 to 1.8 mm; pressure 4826 KiloPascal; outer diameter 1.75 to 2.06 mm; length 100 to 110 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40-6383 | Lumen/Inner Diameter 1.80 mm | In distribution |
| 40-5341 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5370 | Pressure 4826 KiloPascal | In distribution |
| 40-5443 | Pressure 4826 KiloPascal | In distribution |
| 40-5331 | Shape name of distal shaft is SAL2.0 | In distribution |
| 40-5362 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5461 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5481 | Shape name of distal shaft is IR1.5 | In distribution |
| 40-5442 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5470 | Outer Diameter 1.75 mm | In distribution |
| 40-5381 | Shape name of distal shaft is IR1.5 | In distribution |
| 40-5411 | Outer Diameter 1.75 mm | In distribution |
| 40-6375 | Shape name of distal shaft is IL4.5 | In distribution |
| 40-5347 | Pressure 4826 KiloPascal | In distribution |
| 40-5446 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5356 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5346 | Shape name of distal shaft is JR4.5 | In distribution |
| 40-5432 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-6384 | Shape name of distal shaft is IR1.5(SH) | In distribution |
| 40-5441 | Shape name of distal shaft is JL4.0 | In distribution |
| 40-5444 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5375 | Pressure 4826 KiloPascal | In distribution |
| 40-5330 | Pressure 4826 KiloPascal | In distribution |
| 40-5360 | Pressure 4826 KiloPascal | In distribution |
| 40-6371 | Pressure 4826 KiloPascal | In distribution |
| 40-6374 | Shape name of distal shaft is IL4.0(SH) | In distribution |
| 40-5340 | Pressure 4826 KiloPascal | In distribution |
| 40-5475 | Pressure 4826 KiloPascal | In distribution |
| 40-5445 | Pressure 4826 KiloPascal | In distribution |
| 40-5473 | Outer Diameter 1.75 mm | In distribution |
| 40-5311 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5382 | Pressure 4826 KiloPascal | In distribution |
| 40-6373 | Shape name of distal shaft is IL4.0 | In distribution |
| 40-5460 | Shape name of distal shaft is AL1.0 | In distribution |
| 40-6372 | Shape name of distal shaft is IL3.75 | In distribution |
| 40-5482 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5456 | Length 110 cm | In distribution |
| 40-6377 | Shape name of distal shaft is IL3.75(SH) | In distribution |
| 40-5363 | Length 100 cm | In distribution |
| 40-5372 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5462 | Shape name of distal shaft is AL2.0 | In distribution |
| 40-5373 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5357 | Length 100 cm | In distribution |
| 40-5343 | Shape name of distal shaft is JL5.0 | In distribution |
| 40-5361 | Pressure 4826 KiloPascal | In distribution |
| 40-5457 | Outer Diameter 1.75 mm | In distribution |
| 40-5480 | Length 110 cm | In distribution |
| 40-5431 | Pressure 4826 KiloPascal | In distribution |
| 40-5447 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-6380 | Pressure 4826 KiloPascal | In distribution |
| 40-6382 | Lumen/Inner Diameter 1.80 mm | In distribution |
| 40-5430 | Length 110 cm | In distribution |
| 40-5472 | Outer Diameter 1.75 mm | In distribution |
| 40-6311 | Lumen/Inner Diameter 1.80 mm | In distribution |
| 40-6370 | Lumen/Inner Diameter 1.80 mm | In distribution |
| 40-6376 | Length 100 cm | In distribution |
| 40-5332 | Outer Diameter 1.75 mm | In distribution |
| 40-5463 | Shape name of distal shaft is AL3.0 | In distribution |
| 40-5344 | Length 100 cm | In distribution |
| 40-5380 | Lumen/Inner Diameter 1.47 mm | In distribution |
| 40-5440 | Pressure 4826 KiloPascal | In distribution |
| 40-6381 | Lumen/Inner Diameter 1.80 mm | In distribution |
| 40-5345 | Shape name of distal shaft is JR4.0 | In distribution |
| 40-5342 | Pressure 4826 KiloPascal | In distribution |
| 40-6385 | Shape name of distal shaft is IR2.0(SH) | 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 |
|---|---|
| K250751 | 2025-07-17 |
| K113335 | 2012-07-16 |
| K092372 | 2009-09-11 |
| K090040 | 2009-02-06 |
| K082736 | 2008-09-24 |
| K033583 | 2003-12-12 |
| K992051 | 1999-08-10 |
| K915414 | 1992-02-04 |
| K863137 | 1986-10-10 |
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.