Cronus HP – High Pressure Peripheral Balloon Catheter
Cronus HP is an over-the-wire balloon catheter for dilating narrowed peripheral vessels during angioplasty. It is indicated for the femoral, popliteal, iliac, and renal arteries, and for…
Cronus HP is an over-the-wire balloon catheter for dilating narrowed peripheral vessels during angioplasty. It is indicated for the femoral, popliteal, iliac, and renal arteries, and for obstructive lesions in native or synthetic arteriovenous dialysis fistulas.
The dual-lumen catheter tracks over a 0.035-inch guidewire. Once positioned at the narrowing, its balloon is inflated to expand the vessel and then deflated for withdrawal. Markers support positioning under fluoroscopy.
Supply and Anatomical Limits
Cronus HP is sterilized with ethylene oxide and has a four-year shelf life. It is not intended for coronary arteries or the neurovasculature. The range includes different balloon diameters, balloon lengths, and catheter lengths.
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 | 2022-04-22 |
| Record revised | 2023-03-06 (version 2) |
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 4 to 10 mm; balloon length 20 to 80 mm; catheter length 80 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NHP+72080 | Balloon Diameter 7 mm | In distribution |
| NHP+44080 | Balloon Diameter 4 mm | In distribution |
| NHP+93080 | Balloon Diameter 9 mm | In distribution |
| NHP+58080 | Balloon Diameter 5 mm | In distribution |
| NHP+62080 | Balloon Diameter 6 mm | In distribution |
| NHP+94080 | Balloon Diameter 9 mm | In distribution |
| NHP+83080 | Balloon Diameter 8 mm | In distribution |
| NHP+102080 | Balloon Diameter 10 mm | In distribution |
| NHP+48080 | Balloon Diameter 4 mm | In distribution |
| NHP+42080 | Balloon Diameter 4 mm | In distribution |
| NHP+43080 | Balloon Diameter 4 mm | In distribution |
| NHP+82080 | Balloon Diameter 8 mm | In distribution |
| NHP+46080 | Balloon Diameter 4 mm | In distribution |
| NHP+54080 | Balloon Diameter 5 mm | In distribution |
| NHP+96080 | Balloon Diameter 9 mm | In distribution |
| NHP+63080 | Balloon Diameter 6 mm | In distribution |
| NHP+103080 | Balloon Diameter 10 mm | In distribution |
| NHP+92080 | Balloon Diameter 9 mm | In distribution |
| NHP+56080 | Balloon Diameter 5 mm | In distribution |
| NHP+53080 | Balloon Diameter 5 mm | In distribution |
| NHP+73080 | Balloon Diameter 7 mm | In distribution |
| NHP+104080 | Balloon Diameter 10 mm | In distribution |
| NHP+106080 | Balloon Diameter 10 mm | In distribution |
| NHP+52080 | Balloon Diameter 5 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.