Progreat Lambda
Progreat Lambda is a microcatheter for infusing contrast media, hemostatic embolic materials or intra-arterial drugs into peripheral vessels. It is not intended for cerebral, coronary or…
Progreat Lambda is a microcatheter for infusing contrast media, hemostatic embolic materials or intra-arterial drugs into peripheral vessels. It is not intended for cerebral, coronary or other central-circulatory blood vessels.
The single-use catheter is ethylene-oxide sterilized. A PTFE inner liner sits within multilayer polymer tubing reinforced by metal mesh, while a hydrophilic outer coating becomes lubricious when wet with saline or blood.
Listed Item
Micro Catheter System
Sizes and Access
The range offers 1.7F and 1.9F distal sizes and effective lengths from 110 to 175 cm. It accepts guidewires up to 0.016 inch in diameter and includes a radiopaque distal marker.
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 Clinical Supply Co., Ltd., Japan |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Manufacturer |
| 510(k) | K211078 |
| Record published | 2022-04-07 |
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. |
| Packaging | Carton of 5 |
| Sizes | Catheter inner diameter 0.48 mm; outer diameter 0.64 mm; catheter working length 130 to 150 cm; length 165 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CC*M1916AN | Length 165 cm | In distribution |
| CC-MC913SN | Catheter Working Length 130 cm | In distribution |
| CC-MC915SN | Catheter Working Length 150 cm | In distribution |
| CC*M1916DN | Length 165 cm | In distribution |
| CC*M1916SN | Length 165 cm | In distribution |
| CC-MC913DN | Catheter Working Length 130 cm | In distribution |
| CC-MC913AN | Catheter Working Length 130 cm | In distribution |
| CC-MC915DN | Catheter Working Length 150 cm | In distribution |
| CC-MC915AN | Catheter Working Length 150 cm | 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 |
|---|---|
| K211078 | 2021-12-21 |
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.