Fortrex™
PTA A35HPV07100080 Fortrex V04
5manufacturers in China registered for this device type
76catalogue 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) | K142654 |
| Record published | 2024-02-15 |
| Record revised | 2025-07-01 (version 3) |
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: Store the device in a dry area away from sunlight. Do not store catheters where they are directly exposed to organic sol; Special storage condition: Rotate inventory so that the device is used before the Use-by date on the package label.; Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 4 to 12 mm; length 40 to 135 cm; catheter gauge 6 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A35HPV07100080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV12040080 | Length 80.0 cm | In distribution |
| A35HPV08040135 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV06020080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04040040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV06100040 | Length 40.0 cm | In distribution |
| A35HPV05040040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV07100135 | Length 135.0 cm | In distribution |
| A35HPV06080080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV09040080 | Outer Diameter 9.0 mm | In distribution |
| A35HPV05100040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV05040080 | Length 80.0 cm | In distribution |
| A35HPV05020135 | Outer Diameter 5.0 mm | In distribution |
| A35HPV07040135 | Length 135.0 cm | In distribution |
| A35HPV10040080 | Outer Diameter 10.0 mm | In distribution |
| A35HPV07040080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV06020135 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV07100040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV08080135 | Length 135.0 cm | In distribution |
| A35HPV08080080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV07080040 | Outer Diameter 7.0 mm | In distribution |
| A35HPV04020080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV06100135 | Outer Diameter 6.0 mm | In distribution |
| A35HPV08100080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV08100040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV05040135 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV08040040 | Length 40.0 cm | In distribution |
| A35HPV05100080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV05080135 | Outer Diameter 5.0 mm | In distribution |
| A35HPV06040040 | Outer Diameter 6.0 mm | In distribution |
| A35HPV07040040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV06080135 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV09040135 | Length 135.0 cm | In distribution |
| A35HPV09040040 | Length 40.0 cm | In distribution |
| A35HPV07080135 | Outer Diameter 7.0 mm | In distribution |
| A35HPV08080040 | Outer Diameter 8.0 mm | In distribution |
| A35HPV05080040 | Outer Diameter 5.0 mm | In distribution |
| A35HPV04100135 | Length 135.0 cm | In distribution |
| A35HPV04040135 | Length 135.0 cm | In distribution |
| A35HPV06020040 | Length 40.0 cm | In distribution |
| A35HPV12040040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV12080080 | Length 80.0 cm | In distribution |
| A35HPV05080080 | Length 80.0 cm | In distribution |
| A35HPV05020040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV07020080 | Max. Guidewire.89 MM | In distribution |
| A35HPV09080040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV07020040 | Outer Diameter 7.0 mm | In distribution |
| A35HPV08100135 | Outer Diameter 8.0 mm | In distribution |
| A35HPV04080080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV09080080 | Length 80.0 cm | In distribution |
| A35HPV07080080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04020040 | Outer Diameter 4.0 mm | In distribution |
| A35HPV10080080 | Catheter Gauge 7.0 Fr | In distribution |
| A35HPV10080040 | Outer Diameter 10.0 mm | In distribution |
| A35HPV07020080 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04100080 | Length 80.0 cm | In distribution |
| A35HPV08040080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV04080135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV10040135 | Outer Diameter 10.0 mm | In distribution |
| A35HPV06080040 | Outer Diameter 6.0 mm | In distribution |
| A35HPV10040040 | Outer Diameter 10.0 mm | In distribution |
| A35HPV06040080 | Outer Diameter 6.0 mm | In distribution |
| A35HPV05100135 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV05020080 | Length 80.0 cm | In distribution |
| A35HPV04100040 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV04020135 | Catheter Gauge 6.0 Fr | In distribution |
| A35HPV07020135 | Length 135.0 cm | In distribution |
| A35HPV06100080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV10080135 | Outer Diameter 10.0 mm | In distribution |
| A35HPV12080135 | Length 135.0 cm | In distribution |
| A35HPV04040080 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV12040135 | Length 135.0 cm | In distribution |
| A35HPV06040135 | Length 135.0 cm | In distribution |
| A35HPV09080135 | Outer Diameter 9.0 mm | In distribution |
| A35HPV12080040 | Compatible Guidewire 0.89 MM | In distribution |
| A35HPV04080040 | Catheter Gauge 6.0 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
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.