PowerCross
.018
5manufacturers in China registered for this device type
84catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K093286 |
| Record published | 2015-10-09 |
| Record revised | 2023-11-03 (version 7) |
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, expiry date |
| Storage | Special storage condition: Keep dry |
| Sizes | Catheter gauge 4 to 6 Fr; outer diameter 0.5 to 6 mm; length 20 to 200 mm; length 90 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB18W030060090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W040080090 | Length 80 mm | In distribution |
| AB18W050040090 | Outer Diameter 5 mm | In distribution |
| AB18W060040150 | Length 40 mm | In distribution |
| AB18W060120150 | Length 120 mm | In distribution |
| AB18W030100150 | Outer Diameter 3 mm | In distribution |
| AB18W040100090 | Outer Diameter 4 mm | In distribution |
| AB18W060060090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W050020090 | Length 20 mm | In distribution |
| AB18W025020090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W050060150 | Length 60 mm | In distribution |
| AB18W025100150 | Length 100 mm | In distribution |
| AB18W040060150 | Outer Diameter 4 mm | In distribution |
| AB18W040150090 | Length 150 mm | In distribution |
| AB18W060150150 | Outer Diameter 6 mm | In distribution |
| AB18W020040090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W020200090 | Catheter Gauge 4 Fr | In distribution |
| AB18W060020150 | Length 20 mm | In distribution |
| AB18W050100150 | Working Length,150,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W030200090 | Length 200 mm | In distribution |
| AB18W040120150 | Length 120 mm | In distribution |
| AB18W040200090 | Outer Diameter 4 mm | In distribution |
| AB18W030120150 | Length 120 mm | In distribution |
| AB18W030080090 | Outer Diameter 3 mm | In distribution |
| AB18W025040090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W050200090 | Length 200 mm | In distribution |
| AB18W020150150 | Length 150 mm | In distribution |
| AB18W050120090 | Outer Diameter 5 mm | In distribution |
| AB18W030020090 | Outer Diameter 3 mm | In distribution |
| AB18W020040150 | Length 40 mm | In distribution |
| AB18W020150090 | Catheter Gauge 4 Fr | In distribution |
| AB18W040080150 | Outer Diameter 4 mm | In distribution |
| AB18W050150150 | Outer Diameter 5 mm | In distribution |
| AB18W050020150 | Length 20 mm | In distribution |
| AB18W030200150 | Outer Diameter 3 mm | In distribution |
| AB18W060100150 | Length 100 mm | In distribution |
| AB18W060100090 | Length 100 mm | In distribution |
| AB18W025150090 | Catheter Gauge 4 Fr | In distribution |
| AB18W025100090 | Length 100 mm | In distribution |
| AB18W025040150 | Outer Diameter 2.5 mm | In distribution |
| AB18W020020090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W040120090 | Length 120 mm | In distribution |
| AB18W040060090 | Outer Diameter 4 mm | In distribution |
| AB18W030040090 | Length 40 mm | In distribution |
| AB18W060200150 | Outer Diameter 6 mm | In distribution |
| AB18W040200150 | Working Length,150,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W030080150 | Outer Diameter 3 mm | In distribution |
| AB18W020100150 | Length 100 mm | In distribution |
| AB18W025150150 | Length 150 mm | In distribution |
| AB18W060200090 | Length 200 mm | In distribution |
| AB18W050120150 | Length 120 mm | In distribution |
| AB18W030100090 | Outer Diameter 3 mm | In distribution |
| AB18W050080150 | Outer Diameter 5 mm | In distribution |
| AB18W030060150 | Outer Diameter 3 mm | In distribution |
| AB18W040040090 | Outer Diameter 4 mm | In distribution |
| AB18W050080090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W025200090 | Length 200 mm | In distribution |
| AB18W030150090 | Length 150 mm | In distribution |
| AB18W025200150 | Length 200 mm | In distribution |
| AB18W060080150 | Outer Diameter 6 mm | In distribution |
| AB18W030020150 | Working Length,150,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W020020150 | Outer Diameter 2 mm | In distribution |
| AB18W030150150 | Length 150 mm | In distribution |
| AB18W050060090 | Length 60 mm | In distribution |
| AB18W020200150 | Outer Diameter 2 mm | In distribution |
| AB18W050100090 | Catheter Gauge 5 Fr | In distribution |
| AB18W040150150 | Outer Diameter 4 mm | In distribution |
| AB18W060150090 | Outer Diameter 6 mm | In distribution |
| AB18W050150090 | Outer Diameter 5 mm | In distribution |
| AB18W030040150 | Outer Diameter 3 mm | In distribution |
| AB18W030120090 | Length 120 mm | In distribution |
| AB18W025020150 | Length 20 mm | In distribution |
| AB18W060040090 | Length 40 mm | In distribution |
| AB18W060020090 | Wire Size:0.018 IN | In distribution |
| AB18W050200150 | Length 200 mm | In distribution |
| AB18W060120090 | Working Length,90,Centimeter;Wire Size,0.018,Inches;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT; | In distribution |
| AB18W060080090 | Outer Diameter 6 mm | In distribution |
| AB18W060060150 | Outer Diameter 6 mm | In distribution |
| AB18W040020090 | Outer Diameter 4 mm | In distribution |
| AB18W040040150 | Length 40 mm | In distribution |
| AB18W040100150 | Length 100 mm | In distribution |
| AB18W050040150 | Length 40 mm | In distribution |
| AB18W020100090 | Length 100 mm | In distribution |
| AB18W040020150 | Length 20 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic, Inc. | 510(k) number | 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 |
| ev3, Inc. | 510(k) number | 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.