Cronus™ HP – OTW PTA Balloon Catheter
The Cronus HP is an over-the-wire balloon catheter for peripheral angioplasty. Its indications cover the femoral, popliteal, iliac and renal arteries and obstructive lesions of native or…
The Cronus HP is an over-the-wire balloon catheter for peripheral angioplasty. Its indications cover the femoral, popliteal, iliac and renal arteries and obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It is not intended for coronary or neurovascular use.
The dual-lumen catheter advances over a guidewire up to 0.035 inches in diameter. A separate lumen inflates and deflates the distal semi-compliant balloon using contrast medium mixed with saline. Two radiopaque markers identify the balloon segment during positioning.
Configuration
A proximal Y-connector provides separate guidewire and balloon ports. The catheter is supplied sterile in configurations with different balloon diameters, balloon lengths and usable 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) | K151141 |
| Record published | 2016-09-16 |
| Record revised | 2020-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-01-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NCH+63080 | balloon diameter: 6mm | In distribution |
| NCH+73045 | balloon diameter: 7mm | Withdrawn |
| NCH+74045 | catheter length: 45cm | Withdrawn |
| NCH+44045 | balloon diameter: 4mm | Withdrawn |
| NCH+104080 | catheter length: 80cm | Withdrawn |
| NCH+44080 | balloon length: 40mm | Withdrawn |
| NCH+62080 | catheter length: 80cm | Withdrawn |
| NCH+84080 | balloon diameter: 8mm | Withdrawn |
| NCH+62045 | catheter length: 45cm | Withdrawn |
| NCH+43045 | catheter length: 45cm | Withdrawn |
| NCH+106080 | catheter length: 80cm | Withdrawn |
| NCH+94045 | balloon length: 40mm | Withdrawn |
| NCH+72045 | balloon diameter: 7mm | Withdrawn |
| NCH+84045 | balloon diameter: 8mm | Withdrawn |
| NCH+83080 | balloon length: 30mm | Withdrawn |
| NCH+102045 | balloon length: 20mm | Withdrawn |
| NCH+102080 | catheter length: 80cm | Withdrawn |
| NCH+93080 | balloon length: 30mm | Withdrawn |
| NCH+54045 | catheter length: 45cm | Withdrawn |
| NCH+82080 | balloon length: 20mm | Withdrawn |
| NCH+52080 | balloon length: 20mm | Withdrawn |
| NCH+53045 | catheter length: 45cm | Withdrawn |
| NCH+74080 | balloon length: 40mm | Withdrawn |
| NCH+64045 | balloon length: 40mm | Withdrawn |
| NCH+86080 | balloon length: 60mm | Withdrawn |
| NCH+76045 | balloon length: 60mm | Withdrawn |
| NCH+103045 | balloon diameter: 10mm | Withdrawn |
| NCH+96080 | balloon length: 60mm | Withdrawn |
| NCH+56080 | catheter length: 80cm | Withdrawn |
| NCH+86045 | catheter length: 45cm | Withdrawn |
| NCH+63045 | catheter length: 45cm | Withdrawn |
| NCH+92080 | balloon length: 20mm | Withdrawn |
| NCH+66080 | catheter length: 80cm | Withdrawn |
| NCH+92045 | catheter length: 45cm | Withdrawn |
| NCH+93045 | balloon diameter: 9mm | Withdrawn |
| NCH+53080 | balloon diameter: 5mm | Withdrawn |
| NCH+64080 | balloon length: 40mm | Withdrawn |
| NCH+103080 | balloon diameter: 10mm | Withdrawn |
| NCH+82045 | balloon length: 20mm | Withdrawn |
| NCH+73080 | balloon diameter: 7mm | Withdrawn |
| NCH+54080 | balloon length: 40mm | Withdrawn |
| NCH+104045 | balloon length: 40mm | Withdrawn |
| NCH+43080 | balloon length: 30mm | Withdrawn |
| NCH+76080 | catheter length: 80cm | Withdrawn |
| NCH+72080 | balloon length: 20mm | Withdrawn |
| NCH+96045 | balloon length: 60mm | Withdrawn |
| NCH+42045 | balloon diameter: 4mm | Withdrawn |
| NCH+52045 | balloon diameter: 5mm | Withdrawn |
| NCH+83045 | balloon length: 30mm | Withdrawn |
| NCH+106045 | balloon diameter: 10mm | Withdrawn |
| NCH+56045 | balloon length: 60mm | Withdrawn |
| NCH+46045 | balloon diameter: 4mm | Withdrawn |
| NCH+94080 | balloon length: 40mm | Withdrawn |
| NCH+46080 | balloon diameter: 4mm | Withdrawn |
| NCH+66045 | catheter length: 45cm | Withdrawn |
| NCH+42080 | balloon length: 20mm | Withdrawn |
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.