NanoCross™ Elite
PTA AB14W025060090 Nanocross 014 V06
5manufacturers in China registered for this device type
104catalogue numbers in this listing
3510(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 | Medtronic, 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, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K141118 |
| Record published | 2024-03-08 |
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 | Catheter working length 90 to 150 cm; balloon length 20 to 210 mm; balloon diameter 1.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB14W025060090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W025040090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W020100090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W035060090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W050060090 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W030120150 | Balloon Diameter 3.0 mm | In distribution |
| AB14W060100150 | Balloon Diameter 6.0 mm | In distribution |
| AB14W050200090 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W030040150 | Balloon Length 40.0 mm | In distribution |
| AB14W020060150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W030100090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W020080150 | Balloon Diameter 2.0 mm | In distribution |
| AB14W020020090 | Balloon Diameter 2.0 mm | In distribution |
| AB14W020100150 | Balloon Length 100.0 mm | In distribution |
| AB14W025060150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W050040090 | Balloon Length 40.0 mm | In distribution |
| AB14W030020090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W025150150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W020080090 | Balloon Diameter 2.0 mm | In distribution |
| AB14W015040090 | Balloon Diameter 1.5 mm | In distribution |
| AB14W050080150 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W035120090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W035100090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W025100090 | Balloon Length 100.0 mm | In distribution |
| AB14W015020150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W060040090 | Balloon Diameter 6.0 mm | In distribution |
| AB14W020040090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W050120150 | Balloon Length 120.0 mm | In distribution |
| AB14W060040150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W060120090 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W025080150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W060060090 | Balloon Diameter 6.0 mm | In distribution |
| AB14W035040090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W030020150 | Balloon Diameter 3.0 mm | In distribution |
| AB14W060200150 | Balloon Length 200.0 mm | In distribution |
| AB14W050080090 | Balloon Length 80.0 mm | In distribution |
| AB14W035080150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W030210090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W030080090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W025040150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W060020090 | Balloon Length 20.0 mm | In distribution |
| AB14W035150090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W060150150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W020150090 | Balloon Length 150.0 mm | In distribution |
| AB14W020150150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W040080090 | Balloon Length 80.0 mm | In distribution |
| AB14W040040090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W040100090 | Balloon Diameter 4.0 mm | In distribution |
| AB14W025120090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W060150090 | Balloon Length 150.0 mm | In distribution |
| AB14W020210150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W025100150 | Balloon Diameter 2.5 mm | In distribution |
| AB14W060080150 | Balloon Diameter 6.0 mm | In distribution |
| AB14W025020150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W050060150 | Balloon Length 60.0 mm | In distribution |
| AB14W050200150 | Balloon Diameter 5.0 mm | In distribution |
| AB14W060060150 | Balloon Length 60.0 mm | In distribution |
| AB14W035120150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W025210150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W035080090 | Balloon Diameter 3.5 mm | In distribution |
| AB14W030150090 | Balloon Length 150.0 mm | In distribution |
| AB14W050020150 | Balloon Length 20.0 mm | In distribution |
| AB14W030080150 | Balloon Diameter 3.0 mm | In distribution |
| AB14W040020150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W040120150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W050100090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W035060150 | Catheter Working Length 150.0 cm | In distribution |
| AB14W035040150 | Balloon Length 40.0 mm | In distribution |
| AB14W025080090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W030210150 | Balloon Length 210.0 mm | In distribution |
| AB14W020040150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W015040150 | Balloon Diameter 1.5 mm | In distribution |
| AB14W050040150 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W020060090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W060080090 | Balloon Length 80.0 mm | In distribution |
| AB14W025120150 | Balloon Length 120.0 mm | In distribution |
| AB14W025150090 | Balloon Length 150.0 mm | In distribution |
| AB14W025210090 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W040150090 | Balloon Length 150.0 mm | In distribution |
| AB14W050020090 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W040210150 | Minimum sheath inner diameter 4 Fr | In distribution |
| AB14W025020090 | Balloon Length 20.0 mm | In distribution |
| AB14W050150090 | Balloon Length 150.0 mm | In distribution |
| AB14W050120090 | Balloon Length 120.0 mm | In distribution |
| AB14W035020090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W050100150 | Balloon Diameter 5.0 mm | In distribution |
| AB14W040060150 | Balloon Length 60.0 mm | In distribution |
| AB14W020120090 | Catheter Working Length 90.0 cm | In distribution |
| AB14W035100150 | Balloon Diameter 3.5 mm | In distribution |
| AB14W015020090 | Balloon Length 20.0 mm | In distribution |
| AB14W060100090 | Balloon Diameter 6.0 mm | In distribution |
| AB14W060020150 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W020210090 | Balloon Diameter 2.0 – 1.5 MM | In distribution |
| AB14W060200090 | Balloon Diameter 6.0 mm | In distribution |
| AB14W035020150 | Balloon Length 20.0 mm | In distribution |
| AB14W040020090 | Balloon Length 20.0 mm | In distribution |
| AB14W030100150 | Balloon Length 100.0 mm | In distribution |
| AB14W030120090 | Balloon Length 120.0 mm | In distribution |
| AB14W050150150 | Minimum sheath inner diameter 5 Fr | In distribution |
| AB14W030060090 | Balloon Length 60.0 mm | In distribution |
| AB14W060120150 | Balloon Diameter 6.0 mm | In distribution |
| AB14W040100150 | Balloon Length 100.0 mm | In distribution |
| AB14W040060090 | Balloon Diameter 4.0 mm | In distribution |
| AB14W020120150 | Minimum sheath inner diameter 4 Fr | 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 |
|---|---|
| K213631 | 2021-12-15 |
| K121265 | 2012-05-22 |
| K103464 | 2010-12-22 |
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
1 of these is 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 |
|---|---|---|---|---|---|
| 2016-11-10 | Class II | Process control | Medtronic identified an issue with specific models and lots of the PowerCross.018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an ou | 315 | 2017-08-02 |
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.