Chocolate®
PTA CB1413540120 Chocolate 014 V04
5manufacturers in China registered for this device type
54catalogue 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) | K130414 |
| Record published | 2021-06-17 |
| Record revised | 2023-08-07 (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 in a dry, cool place. |
| Sizes | Length 120 to 150 cm; balloon length 40 to 120 mm; balloon diameter 2.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB1413540120OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812060080OTW | Length 120.0 cm | In distribution |
| CB1812050120OTW | Length 120.0 cm | In distribution |
| CB1413535040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812050040OTW | Balloon Length 40.0 mm | In distribution |
| CB1812060120OTW | Balloon Diameter 6.0 mm | In distribution |
| CB1415025120OTW | 5 F Recommended Sheath Size | In distribution |
| CB1812050120OTW | Balloon Diameter 5.0 mm | In distribution |
| CB1415030120OTW | Balloon Length 120.0 mm | In distribution |
| CB1413535080OTW | Balloon Diameter 3.5 mm | In distribution |
| CB1413535120OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1413540040OTW | Length 135.0 cm | In distribution |
| CB1415030120OTW | 5 F Recommended Sheath Size | In distribution |
| CB1415025080OTW | Length 150.0 cm | In distribution |
| CB1812060080OTW | .018 IN Maximum Guidewire Diameter | In distribution |
| CB1812060120OTW | .018 IN Maximum Guidewire Diameter | In distribution |
| CB1812050120OTW | 6 F Recommended Sheath Size | In distribution |
| CB1415030080OTW | Length 150.0 cm | In distribution |
| CB1812060040OTW | Balloon Diameter 6.0 mm | In distribution |
| CB1415030040OTW | Length 150.0 cm | In distribution |
| CB1413535080OTW | Balloon Diameter 3.5 mm | In distribution |
| CB1413540080OTW | 5 F Recommended Sheath Size | In distribution |
| CB1415025080OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812060080OTW | 6 F Recommended Sheath Size | In distribution |
| CB1415030120OTW | 5 F Recommended Sheath Size | In distribution |
| CB1415025120OTW | Balloon Length 120.0 mm | In distribution |
| CB1413540120OTW | 5 F Recommended Sheath Size | In distribution |
| CB1812050040OTW | Length 120.0 cm | In distribution |
| CB1415030040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812050040OTW | 6 F Recommended Sheath Size | In distribution |
| CB1413535120OTW | Balloon Diameter 3.5 mm | In distribution |
| CB1812050080OTW | Balloon Length 80.0 mm | In distribution |
| CB1415025040OTW | 5 F Recommended Sheath Size | In distribution |
| CB1413540080OTW | Balloon Length 80.0 mm | In distribution |
| CB1413535040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1415030040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1413535080OTW | Length 135.0 cm | In distribution |
| CB1413540040OTW | Balloon Diameter 4.0 mm | In distribution |
| CB1413540040OTW | Length 135.0 cm | In distribution |
| CB1812050080OTW | Balloon Length 80.0 mm | In distribution |
| CB1413535120OTW | Length 135.0 cm | In distribution |
| CB1415030080OTW | Balloon Length 80.0 mm | In distribution |
| CB1415025120OTW | Balloon Diameter 2.5 mm | In distribution |
| CB1413540080OTW | Length 135.0 cm | In distribution |
| CB1415025080OTW | Length 150.0 cm | In distribution |
| CB1812060040OTW | .018 IN Maximum Guidewire Diameter | In distribution |
| CB1812060120OTW | Balloon Length 120.0 mm | In distribution |
| CB1413535040OTW | 5 F Recommended Sheath Size | In distribution |
| CB1812060040OTW | Balloon Length 40.0 mm | In distribution |
| CB1413540120OTW | Balloon Length 120.0 mm | In distribution |
| CB1415025040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1415030080OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812050080OTW | Balloon Diameter 5.0 mm | In distribution |
| CB1415025040OTW | Length 150.0 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.