EverCross™
PTA AB35W09080080 Evercross 035 V10
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) | K190753 |
| Record published | 2024-03-07 |
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 Dry; Special storage condition: Keep away from sunlight |
| Sizes | Balloon length 20 to 200 mm; catheter working length 40 to 135 cm; balloon diameter 3 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB35W09080080 | Balloon Length 80.0 mm | In distribution |
| AB35W09060080 | Balloon Diameter 9.0 mm | In distribution |
| AB35W05030080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W05080135 | Balloon Diameter 5.0 mm | In distribution |
| AB35W05120080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06020080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W10020135 | Balloon Diameter 10.0 mm | In distribution |
| AB35W03040080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W07060135 | Balloon Length 60.0 mm | In distribution |
| AB35W03080135 | Balloon Diameter 3.0 mm | In distribution |
| AB35W05030135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W07040040 | Balloon Diameter 7.0 mm | In distribution |
| AB35W06150080 | Balloon Diameter 6.0 mm | In distribution |
| AB35W08040040 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W09020080 | Balloon Diameter 9.0 mm | In distribution |
| AB35W06060135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W12020135 | Minimum sheath inner diameter 7 FR | In distribution |
| AB35W10030080 | Balloon Length 30.0 mm | In distribution |
| AB35W07020135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W04120135 | Balloon Diameter 4.0 mm | In distribution |
| AB35W04040135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W07200080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W05060135 | Balloon Diameter 5.0 mm | In distribution |
| AB35W04150080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W08030080 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W05080040 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W03080080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W06020040 | Catheter Working Length 40.0 cm | In distribution |
| AB35W05100080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W05060080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06080135 | Balloon Length 80.0 mm | In distribution |
| AB35W04060135 | Balloon Diameter 4.0 mm | In distribution |
| AB35W09080135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W05120135 | Balloon Diameter 5.0 mm | In distribution |
| AB35W09030080 | Balloon Length 30.0 mm | In distribution |
| AB35W03030135 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W08060040 | Balloon Length 60.0 mm | In distribution |
| AB35W10040135 | Balloon Length 40.0 mm | In distribution |
| AB35W07120080 | Balloon Length 120.0 mm | In distribution |
| AB35W06100135 | Catheter Working Length 135.0 cm | In distribution |
| AB35W03150080 | Balloon Diameter 3.0 mm | In distribution |
| AB35W06030080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W05040135 | Balloon Length 40.0 mm | In distribution |
| AB35W05150135 | Balloon Diameter 5.0 mm | In distribution |
| AB35W06040080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W03200080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W10040080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W04020135 | Balloon Length 20.0 mm | In distribution |
| AB35W06030135 | Balloon Length 30.0 mm | In distribution |
| AB35W04100080 | Balloon Diameter 4.0 mm | In distribution |
| AB35W05030040 | Balloon Length 30.0 mm | In distribution |
| AB35W05040040 | Catheter Working Length 40.0 cm | In distribution |
| AB35W04080080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W04200080 | Balloon Diameter 4.0 mm | In distribution |
| AB35W07040080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W06020135 | Balloon Diameter 6.0 mm | In distribution |
| AB35W03020080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W10060080 | Balloon Diameter 10.0 mm | In distribution |
| AB35W03200135 | Balloon Diameter 3.0 mm | In distribution |
| AB35W04120080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W04200135 | Balloon Diameter 4.0 mm | In distribution |
| AB35W10060135 | Minimum sheath inner diameter 7 FR | In distribution |
| AB35W05080080 | Balloon Diameter 5.0 mm | In distribution |
| AB35W07030135 | Balloon Length 30.0 mm | In distribution |
| AB35W07040135 | Balloon Diameter 7.0 mm | In distribution |
| AB35W03030080 | Balloon Diameter 3.0 mm | In distribution |
| AB35W08080135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W03060080 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W10030135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W12040080 | Balloon Length 40.0 mm | In distribution |
| AB35W08020135 | Balloon Length 20.0 mm | In distribution |
| AB35W09060135 | Minimum sheath inner diameter 6 FR | In distribution |
| AB35W06080080 | Catheter Working Length 80.0 cm | In distribution |
| AB35W04150135 | Balloon Diameter 4.0 mm | In distribution |
| AB35W06040040 | Minimum sheath inner diameter 5 FR | In distribution |
| AB35W04030080 | Catheter Working Length 80.0 cm | 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.