NanoCross™ Elite
NanoCross Elite is an over-the-wire balloon catheter for dilating narrowed peripheral arteries and obstructive lesions in native or synthetic arteriovenous dialysis fistulas. It is also…
NanoCross Elite is an over-the-wire balloon catheter for dilating narrowed peripheral arteries and obstructive lesions in native or synthetic arteriovenous dialysis fistulas. It is also indicated for peripheral stent post-dilatation. Its arterial applications include the iliac, femoral, popliteal, infrapopliteal and renal vessels.
The catheter passes over a guidewire up to 0.014 inches in diameter. A separate balloon lumen carries a contrast-medium and saline mixture to inflate and deflate the semi-compliant balloon. Two radiopaque bands mark the balloon’s working section to help position it at the narrowing.
Listed Item
PTA AB14W035060150 Nanocross 014 V04
Catheter Design
A tapered, atraumatic tip leads the catheter, and the distal portion has a lubricious coating. The proximal manifold separates the guidewire passage, marked THRU, from the balloon inflation passage.
5manufacturers in China registered for this device type
198catalogue numbers in this listing
7510(k) clearances naming this product code
3recalls on this code
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 | ev3, Inc., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K141118 |
| Record published | 2016-07-10 |
| Record revised | 2024-05-10 (version 4) |
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 |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
| Sizes | Length 20 to 210 mm; outer diameter 1.5 to 6 mm; catheter gauge 4 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB14W035060150 | Length 60.0 mm | In distribution |
| AB14W035060090 | Outer Diameter 3.5 mm | In distribution |
| AB14W025080150 | Length 80.0 mm | In distribution |
| AB14W015040150 | Max. Guidewire.36 MM | In distribution |
| AB14W030100090 | Length 100.0 mm | In distribution |
| AB14W060120090 | Max. Guidewire.36 MM | In distribution |
| AB14W035150090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W060020090 | Outer Diameter 6.0 mm | In distribution |
| AB14W025150150 | Outer Diameter 2.5 mm | In distribution |
| AB14W040060150 | Max. Guidewire.36 MM | In distribution |
| AB14W035120150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W020100090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W060040090 | Outer Diameter 6.0 mm | In distribution |
| AB14W040080090 | Length 80.0 mm | In distribution |
| AB14W050200090 | Length 200.0 mm | In distribution |
| AB14W050120090 | Outer Diameter 5.0 mm | In distribution |
| AB14W040120090 | Outer Diameter 4.0 mm | In distribution |
| AB14W060100090 | Catheter Gauge 5.0 Fr | In distribution |
| AB14W050040150 | Outer Diameter 5.0 mm | In distribution |
| AB14W060100090 | Length 100.0 mm | In distribution |
| AB14W020040090 | Outer Diameter 2.0 mm | In distribution |
| AB14W035100090 | Outer Diameter 3.5 mm | In distribution |
| AB14W015020150 | Max. Guidewire.36 MM | In distribution |
| AB14W060020150 | Length 20.0 mm | In distribution |
| AB14W050060150 | Length 60.0 mm | In distribution |
| AB14W015040090 | Length 40.0 mm | In distribution |
| AB14W035100090 | Outer Diameter 3.5 mm | In distribution |
| AB14W035080150 | Outer Diameter 3.5 mm | In distribution |
| AB14W025040090 | Outer Diameter 2.5 mm | In distribution |
| AB14W025020150 | Outer Diameter 2.5 mm | In distribution |
| AB14W030040150 | Length 40.0 mm | In distribution |
| AB14W020040090 | Length 40.0 mm | In distribution |
| AB14W050120090 | Max. Guidewire.36 MM | In distribution |
| AB14W050060090 | Length 60.0 mm | In distribution |
| AB14W035120090 | Length 120.0 mm | In distribution |
| AB14W050080150 | Catheter Gauge 5.0 Fr | In distribution |
| AB14W040150090 | Length 150.0 mm | In distribution |
| AB14W050080090 | Length 80.0 mm | In distribution |
| AB14W050120150 | Outer Diameter 5.0 mm | In distribution |
| AB14W060200150 | Max. Guidewire.36 MM | In distribution |
| AB14W020120150 | Outer Diameter 2.0 mm | In distribution |
| AB14W020100090 | Outer Diameter 2.0 mm | In distribution |
| AB14W020080090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W030120150 | Length 120.0 mm | In distribution |
| AB14W050100150 | Outer Diameter 5.0 mm | In distribution |
| AB14W015020090 | Outer Diameter 1.5 mm | In distribution |
| AB14W025150090 | Outer Diameter 2.5 mm | In distribution |
| AB14W050100090 | Length 100.0 mm | In distribution |
| AB14W050080150 | Length 80.0 mm | In distribution |
| AB14W060040150 | Max. Guidewire.36 MM | In distribution |
| AB14W025040150 | Outer Diameter 2.5 mm | In distribution |
| AB14W025020090 | Outer Diameter 2.5 mm | In distribution |
| AB14W030040090 | Outer Diameter 3.0 mm | In distribution |
| AB14W050040150 | Length 40.0 mm | In distribution |
| AB14W050120150 | Outer Diameter 5.0 mm | In distribution |
| AB14W020060090 | Max. Guidewire.36 MM | In distribution |
| AB14W025040090 | Max. Guidewire.36 MM | In distribution |
| AB14W020210090 | Length 210.0 mm | In distribution |
| AB14W025210150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W060080090 | Length 80.0 mm | In distribution |
| AB14W030150090 | Length 150.0 mm | In distribution |
| AB14W020060090 | Outer Diameter 2.0 mm | In distribution |
| AB14W025120090 | Outer Diameter 2.5 mm | In distribution |
| AB14W060060090 | Outer Diameter 6.0 mm | In distribution |
| AB14W035080150 | Outer Diameter 3.5 mm | In distribution |
| AB14W060080090 | Max. Guidewire.36 MM | In distribution |
| AB14W035060150 | Max. Guidewire.36 MM | In distribution |
| AB14W035060090 | Outer Diameter 3.5 mm | In distribution |
| AB14W050200150 | Length 200.0 mm | In distribution |
| AB14W035080090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W050200150 | Length 200.0 mm | In distribution |
| AB14W050100090 | Max. Guidewire.36 MM | In distribution |
| AB14W025040150 | Length 40.0 mm | In distribution |
| AB14W040210150 | Length 210.0 mm | In distribution |
| AB14W025210090 | Length 210.0 mm | In distribution |
| AB14W035040150 | Length 40.0 mm | In distribution |
| AB14W025210150 | Length 210.0 mm | In distribution |
| AB14W040080090 | Length 80.0 mm | In distribution |
| AB14W060040090 | Outer Diameter 6.0 mm | In distribution |
| AB14W060120150 | Outer Diameter 6.0 mm | In distribution |
| AB14W030080150 | Outer Diameter 3.0 mm | In distribution |
| AB14W060020150 | Max. Guidewire.36 MM | In distribution |
| AB14W030080090 | Outer Diameter 3.0 mm | In distribution |
| AB14W025120150 | Outer Diameter 2.5 mm | In distribution |
| AB14W025150090 | Length 150.0 mm | In distribution |
| AB14W040120090 | Outer Diameter 4.0 mm | In distribution |
| AB14W035100150 | Length 100.0 mm | In distribution |
| AB14W060100150 | Max. Guidewire.36 MM | In distribution |
| AB14W025150150 | Length 150.0 mm | In distribution |
| AB14W020210150 | Length 210.0 mm | In distribution |
| AB14W030020090 | Outer Diameter 3.0 mm | In distribution |
| AB14W015020090 | Length 20.0 mm | In distribution |
| AB14W030100150 | Length 100.0 mm | In distribution |
| AB14W035040090 | Length 40.0 mm | In distribution |
| AB14W035080090 | Outer Diameter 3.5 mm | In distribution |
| AB14W020150150 | Length 150.0 mm | In distribution |
| AB14W050060090 | Outer Diameter 5.0 mm | In distribution |
| AB14W020120150 | Length 120.0 mm | In distribution |
| AB14W030060150 | Length 60.0 mm | In distribution |
| AB14W020060150 | Max. Guidewire.36 MM | In distribution |
| AB14W025080150 | Outer Diameter 2.5 mm | In distribution |
| AB14W060080150 | Length 80.0 mm | In distribution |
| AB14W030080090 | Length 80.0 mm | In distribution |
| AB14W030120090 | Max. Guidewire.36 MM | In distribution |
| AB14W040210090 | Length 210.0 mm | In distribution |
| AB14W060060150 | Outer Diameter 6.0 mm | In distribution |
| AB14W020120090 | Length 120.0 mm | In distribution |
| AB14W025080090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W030100150 | Outer Diameter 3.0 mm | In distribution |
| AB14W030210090 | Max. Guidewire.36 MM | In distribution |
| AB14W060080150 | Max. Guidewire.36 MM | In distribution |
| AB14W015040090 | Length 40.0 mm | In distribution |
| AB14W030040150 | Length 40.0 mm | In distribution |
| AB14W025120090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W060020090 | Length 20.0 mm | In distribution |
| AB14W025080090 | Length 80.0 mm | In distribution |
| AB14W020040150 | Outer Diameter 2.0 mm | In distribution |
| AB14W035020090 | Outer Diameter 3.5 mm | In distribution |
| AB14W050150090 | Outer Diameter 5.0 mm | In distribution |
| AB14W020020090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W030020150 | Outer Diameter 3.0 mm | In distribution |
| AB14W020150150 | Length 150.0 mm | In distribution |
| AB14W020080150 | Outer Diameter 2.0 mm | In distribution |
| AB14W025210090 | Length 210.0 mm | In distribution |
| AB14W060060150 | Outer Diameter 6.0 mm | In distribution |
| AB14W050020150 | Catheter Gauge 5.0 Fr | In distribution |
| AB14W060120150 | Outer Diameter 6.0 mm | In distribution |
| AB14W030080150 | Length 80.0 mm | In distribution |
| AB14W025020150 | Length 20.0 mm | In distribution |
| AB14W015040150 | Outer Diameter 1.5 mm | In distribution |
| AB14W020210150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W040060090 | Outer Diameter 4.0 mm | In distribution |
| AB14W025020090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W025100090 | Length 100.0 mm | In distribution |
| AB14W060150150 | Outer Diameter 6.0 mm | In distribution |
| AB14W060200090 | Catheter Gauge 6.0 Fr | In distribution |
| AB14W035210150 | Outer Diameter 3.5 mm | In distribution |
| AB14W050040090 | Outer Diameter 5.0 mm | In distribution |
| AB14W040100150 | Outer Diameter 4.0 mm | In distribution |
| AB14W035040090 | Length 40.0 mm | In distribution |
| AB14W060150090 | Outer Diameter 6.0 mm | In distribution |
| AB14W035020090 | Outer Diameter 3.5 mm | In distribution |
| AB14W035040150 | Outer Diameter 3.5 mm | In distribution |
| AB14W025100150 | Outer Diameter 2.5 mm | In distribution |
| AB14W040120150 | Outer Diameter 4.0 mm | In distribution |
| AB14W050020150 | Outer Diameter 5.0 mm | In distribution |
| AB14W060200150 | Length 200.0 mm | In distribution |
| AB14W060150090 | Length 150.0 mm | In distribution |
| AB14W050020090 | Length 20.0 mm | In distribution |
| AB14W030150090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W030060090 | Outer Diameter 3.0 mm | In distribution |
| AB14W030100090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W025060090 | Length 60.0 mm | In distribution |
| AB14W030210150 | Outer Diameter 3.0 – 2.5 MM | In distribution |
| AB14W030120090 | Length 120.0 mm | In distribution |
| AB14W050060150 | Max. Guidewire.36 MM | In distribution |
| AB14W030020150 | Outer Diameter 3.0 mm | In distribution |
| AB14W030020090 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W020210090 | Length 210.0 mm | In distribution |
| AB14W050200090 | Outer Diameter 5.0 mm | In distribution |
| AB14W030210150 | Length 210.0 mm | In distribution |
| AB14W020120090 | Outer Diameter 2.0 mm | In distribution |
| AB14W050100150 | Length 100.0 mm | In distribution |
| AB14W030210090 | Outer Diameter 3.0 mm | In distribution |
| AB14W030060150 | Max. Guidewire.36 MM | In distribution |
| AB14W020100150 | Length 100.0 mm | In distribution |
| AB14W020080090 | Length 80.0 mm | In distribution |
| AB14W025120150 | Length 120.0 mm | In distribution |
| AB14W035020150 | Length 20.0 mm | In distribution |
| AB14W060100150 | Length 100.0 mm | In distribution |
| AB14W060060090 | Length 60.0 mm | In distribution |
| AB14W040080150 | Outer Diameter 4.0 mm | In distribution |
| AB14W020020090 | Length 20.0 mm | In distribution |
| AB14W050150150 | Outer Diameter 5.0 mm | In distribution |
| AB14W020040150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W030120150 | Outer Diameter 3.0 mm | In distribution |
| AB14W035120090 | Length 120.0 mm | In distribution |
| AB14W060120090 | Length 120.0 mm | In distribution |
| AB14W050040090 | Outer Diameter 5.0 mm | In distribution |
| AB14W030060090 | Outer Diameter 3.0 mm | In distribution |
| AB14W025060150 | Outer Diameter 2.5 mm | In distribution |
| AB14W050020090 | Length 20.0 mm | In distribution |
| AB14W060200090 | Outer Diameter 6.0 mm | In distribution |
| AB14W060040150 | Outer Diameter 6.0 mm | In distribution |
| AB14W020150090 | Length 150.0 mm | In distribution |
| AB14W015020150 | Outer Diameter 1.5 mm | In distribution |
| AB14W060150150 | Catheter Gauge 5.0 Fr | In distribution |
| AB14W020080150 | Length 80.0 mm | In distribution |
| AB14W025100150 | Max. Guidewire.36 MM | In distribution |
| AB14W035100150 | Outer Diameter 3.5 mm | In distribution |
| AB14W035020150 | Length 20.0 mm | In distribution |
| AB14W020060150 | Length 60.0 mm | In distribution |
| AB14W050080090 | Length 80.0 mm | In distribution |
| AB14W020100150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W035150150 | Catheter Gauge 4.0 Fr | In distribution |
| AB14W050150090 | Outer Diameter 5.0 mm | In distribution |
| AB14W020150090 | Outer Diameter 2.0 mm | In distribution |
| AB14W050150150 | Outer Diameter 5.0 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 |
|---|---|
| K141118 | 2014-07-18 |
| K132777 | 2013-09-26 |
| K130911 | 2013-05-24 |
| K123544 | 2013-02-12 |
| K110319 | 2011-04-14 |
| K103322 | 2010-12-06 |
| K093286 | 2009-11-13 |
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 |
|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2024-12-10 | Class II | Process change control | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. | 5189 units |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-08-26 | Class II | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 4286 devices | 2023-06-09 |
| 2016-03-29 | Class II | Labeling False and Misleading | Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018″ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled. | 27 (25 US, 2 OUS) | 2017-05-19 |
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.