Hermes NC PTA Balloon Dilatation Catheter
The Hermes NC PTA Balloon Dilatation Catheter widens narrowed peripheral arteries and obstructed native or synthetic arteriovenous dialysis fistulas. It is also intended to expand stents…
The Hermes NC PTA Balloon Dilatation Catheter widens narrowed peripheral arteries and obstructed native or synthetic arteriovenous dialysis fistulas. It is also intended to expand stents after deployment in the peripheral vasculature. The catheter advances over a guidewire and carries a noncompliant balloon near its tip.
Its two coaxial lumens provide separate paths for the guidewire and balloon inflation. Inflation fluid enters through a side port, while the straight entry port leads to the guidewire lumen. Radiopaque marker bands identify the balloon section to help position it across the narrowing.
Guidewire Compatibility
The Hermes NC configuration is compatible with a 0.035-inch guidewire. The catheter does not include a separate lumen for distal contrast injection or distal pressure measurement.
5manufacturers in China registered for this device type
168catalogue 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 |
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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 |
|---|---|
| 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.