Cronus HP PTA Balloon Catheter
Cronus HP is an over-the-wire balloon catheter for peripheral angioplasty. A semi-compliant balloon sits near its flush-cut distal tip. Two radiopaque markers identify the balloon’s…
Cronus HP is an over-the-wire balloon catheter for peripheral angioplasty. A semi-compliant balloon sits near its flush-cut distal tip. Two radiopaque markers identify the balloon’s position relative to the narrowed vessel.
Its proximal Y-connector separates the guidewire and balloon lumens. The central guidewire lumen extends to the tip and accepts a wire up to 0.035 inch. The other lumen carries contrast medium and saline for balloon inflation and deflation.
Balloon and Shaft Options
Balloon diameters range from 4 to 10 mm, with balloon lengths from 20 to 80 mm. Catheter lengths are 45 or 80 cm. The family is ethylene oxide sterilized and intended for peripheral vessels and dialysis fistula lesions; coronary and neurovascular use are excluded.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Nipro Medical Corporation, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Complaint-file establishment, Exporter |
| 510(k) | K190037 |
| Record published | 2019-11-15 |
| Record revised | 2023-03-06 (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 |
| Sizes | Balloon diameter 6 to 8 mm; balloon length 40 to 80 mm; catheter length 80 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NHP+88080 | Balloon Diameter 8 mm | In distribution |
| NHP+68080 | Balloon Length 80 mm | In distribution |
| NHP+64080 | Catheter Length 80 cm | In distribution |
| NHP+78080 | Balloon Diameter 7 mm | In distribution |
| NHP+84080 | Balloon Diameter 8 mm | In distribution |
| NHP+66080 | Balloon Length 60 mm | In distribution |
| NHP+86080 | Balloon Diameter 8 mm | In distribution |
| NHP+74080 | Balloon Diameter 7 mm | In distribution |
| NHP+76080 | Balloon Diameter 7 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Parafleet SC 018 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 1,460 |
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | OrbusNeich Medical (Shenzhen) Co., Ltd. | 832 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 667 |
| Parafleet SC 014 PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 572 |
| Minerva PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 504 |
| Advocate | Arravasc, Ltd. | 441 |
| Ultraverse® 035 PTA Dilatation Catheter | Bard Peripheral Vascular, Inc. | 361 |
| Polux PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 359 |
| Advance | Cook Incorporated | 355 |
| Pacific™ Plus | Medtronic, Inc. | 347 |
| EverCross™ | ev3, Inc. | 316 |
| Achilles NC PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 297 |
Showing 12 of 167. All products under Catheter, Angioplasty, Peripheral, Transluminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190037 | 2019-10-24 |
| K151141 | 2016-01-14 |
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.