Angios Classic Angiographic Convenience Kit
Angiographic Convenience Kit, 6F
11manufacturers in China registered for this device type
14catalogue 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 | Oscor 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K092118 |
| Record published | 2017-11-16 |
| Record revised | 2026-02-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Distribution end date | 2018-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ANG4-0042 | JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm | In distribution |
| ANG4-0041 | Maximum Recommended Guidewire 0.038 in | In distribution |
| ANG4-0240 | Recommended Pressure Limit: 1200 psi max. | In distribution |
| ANG4-0239 | Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc | In distribution |
| ANG4-0040 | Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc | In distribution |
| ANG4-0242 | Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc | In distribution |
| ANG4-0039 | Maximum Recommended Guidewire 0.038 in | In distribution |
| ANG4-0241 | JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm | In distribution |
| ANG4-0442 | Flow Rate: JR: 32 mL/sec, JL: 29 mL/sec, PT: 33 mL/sec | In distribution |
| ANG4-0237 | Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 19 mL/sec | Withdrawn |
| ANG4-0037 | Guidewire – Length: 150 cm, OD: 0.035 in | Withdrawn |
| ANG4-0238 | Adelante Sigma Introducer Guidewire – Length: 50 cm, OD: 0.038 in | Withdrawn |
| ANG4-0038 | Pigtail Side Holes: 5 | Withdrawn |
| ETANG4-0342 | Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 34 mL/sec | 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 |
|---|---|
| K092118 | 2010-01-13 |
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.