Achilles NC PTA Balloon Dilatation Catheter
Achilles NC is an over-the-wire balloon catheter for peripheral angioplasty, including narrowed arteries and obstructive dialysis-fistula lesions. A noncompliant nylon balloon near the…
Achilles NC is an over-the-wire balloon catheter for peripheral angioplasty, including narrowed arteries and obstructive dialysis-fistula lesions. A noncompliant nylon balloon near the distal tip provides the dilating element.
Its coaxial double-lumen shaft separates balloon inflation from guidewire passage. Radiopaque marker bands identify the balloon’s dilating segment for positioning under imaging.
Guidewire Configuration
Achilles NC uses a 0.018-inch guidewire. It belongs to a related family that includes 0.014-inch Castor NC and 0.035-inch Hermes NC catheters. Balloon dimensions and configurations vary within that family, so guidewire compatibility follows the named catheter model.
5manufacturers in China registered for this device type
297catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Brosmed Medical Co., Ltd., China |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K160941 |
| Record published | 2017-06-30 |
| Record revised | 2025-11-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
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Showing 250 of 297 catalogue numbers.
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 |
| Castor 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 |
|---|---|
| K243704 | 2025-02-27 |
| K212215 | 2022-07-19 |
| K160941 | 2016-12-13 |
| K160256 | 2016-07-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Brosmed Medical Co., Ltd. | 510(k) number | 2018-12-14 | Class II | Employee error | Incorrect (higher) Rated Burst Pressure information printed on label. | 400 | 2020-12-11 |
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.