Progreat
PROGREAT Microcatheter Coaxial System
5manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Terumo Corp., Japan |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-03-06 |
| Record revised | 2019-03-21 (version 3) |
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, pack of 5 |
| Sizes | Outer diameter 0.67 to 0.93 mm; length 110 to 150 cm; lumen/inner diameter 0.49 to 0.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MC*PC2013Y | Outer Diameter 0.67 mm | In distribution |
| MC*PE27131Y | Outer Diameter 0.90 mm | In distribution |
| MC*PV2415ZRA | Outer Diameter 0.8 mm | In distribution |
| MC*PC2711Y | Outer Diameter 0.90 mm | In distribution |
| MC*PC2013ZRA | Outer Diameter 0.67 mm | In distribution |
| MC*PB2813Y | Length 130 cm | In distribution |
| MC*PP28151YB | Lumen/Inner Diameter 0.70 mm | In distribution |
| MC*PV2815Y | Clinically Relevant Size 1 is relative to catheter distal end. And other Clinically Relevant Sizes are relative to catheter shaft. | In distribution |
| MC*PE28151YB | Outer Diameter 0.93 mm | In distribution |
| MC*PB2413ZRA | Lumen/Inner Diameter 0.57 mm | In distribution |
| MC*PE28111YB | Clinically Relevant Size 1 is relative to catheter distal end. And other Clinically Relevant Sizes are relative to catheter shaft. | In distribution |
| MC*PC2013ZRC | Outer Diameter 0.67 mm | In distribution |
| MC*PV2415ZRC | Lumen/Inner Diameter 0.57 mm | In distribution |
| MC*PB2411Y | Outer Diameter 0.80 mm | In distribution |
| MC*PE27151Y | Lumen/Inner Diameter 0.65 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082519 | 2008-09-26 |
| K033913 | 2004-03-11 |
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.