Chocolate®
PTA CB1415025120 Chocolate 014 V03
5manufacturers in China registered for this device type
18catalogue numbers in this listing
7510(k) clearances naming this product code
3recalls on this code
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 | ev3, 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, Manufacturer, Exporter |
| 510(k) | K130414 |
| Record published | 2020-06-15 |
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 diameter 2.5 to 6 mm; balloon length 40 to 120 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CB1415025120OTW | Length 150.0 cm | In distribution |
| CB1812060040OTW | Balloon Diameter 6.0 mm | In distribution |
| CB1415030040OTW | Length 150.0 cm | In distribution |
| CB1413535120OTW | Balloon Diameter 3.5 mm | In distribution |
| CB1413540120OTW | Balloon Length 120.0 mm | In distribution |
| CB1413540040OTW | Balloon Diameter 4.0 mm | In distribution |
| CB1415030120OTW | Length 150.0 cm | In distribution |
| CB1415025080OTW | 5 F Recommended Sheath Size | In distribution |
| CB1415025040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1812060120OTW | 6 F Recommended Sheath Size | In distribution |
| CB1415030080OTW | 5 F Recommended Sheath Size | In distribution |
| CB1812050080OTW | Length 120.0 cm | In distribution |
| CB1413540080OTW | 5 F Recommended Sheath Size | In distribution |
| CB1413535040OTW | .014 IN Maximum Guidewire Diameter | In distribution |
| CB1413535080OTW | Balloon Length 80.0 mm | In distribution |
| CB1812060080OTW | Balloon Diameter 6.0 mm | In distribution |
| CB1812050120OTW | Length 120.0 cm | In distribution |
| CB1812050040OTW | 6 F Recommended Sheath Size | 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 |
|---|---|
| K141118 | 2014-07-18 |
| K132777 | 2013-09-26 |
| K130911 | 2013-05-24 |
| K123544 | 2013-02-12 |
| K110319 | 2011-04-14 |
| K103322 | 2010-12-06 |
| K093286 | 2009-11-13 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 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 | |
| 2020-08-26 | Class II | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 4286 devices | 2023-06-09 |
| 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.