Sleek OTW PTA Dilatation Catheter
Sleek OTW PTA Dilatation Catheter 2.5mm x 120mm balloon, 150cm shaft
5manufacturers in China registered for this device type
44catalogue numbers in this listing
5510(k) clearances naming this product 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 | Clearstream Technologies Ltd., Ireland |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K102035 |
| Record published | 2016-09-16 |
| Record revised | 2024-01-31 (version 5) |
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 |
| Distribution end date | 2024-01-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 426-2512X | Balloon Length, 120 Millimeter | In distribution |
| 426-1510X | Balloon Diameter, 1.5 Millimeter | In distribution |
| 426-2515X | Balloon Length, 150 Millimeter | In distribution |
| 426-2004X | Shaft Length, 150 Centimeter | In distribution |
| 426-4022X | Shaft Length, 150 Centimeter | In distribution |
| 426-5008X | Balloon Length, 80 Millimeter | In distribution |
| 426-2015X | Shaft Length, 150 Centimeter | In distribution |
| 426-5002X | Balloon Length, 20 Millimeter | In distribution |
| 426-3028X | Balloon Length, 280 Millimeter | In distribution |
| 426-3002X | Balloon Diameter, 3.0 Millimeter | In distribution |
| 426-2502X | Balloon Length, 20 Millimeter | In distribution |
| 426-3522X | Shaft Length, 150 Centimeter | In distribution |
| 426-2510X | Balloon Diameter, 2.5 Millimeter | In distribution |
| 426-3515X | Shaft Length, 150 Centimeter | In distribution |
| 426-2504X | Balloon Length, 40 Millimeter | In distribution |
| 426-2008X | Shaft Length, 150 Centimeter | In distribution |
| 426-2012X | Balloon Diameter, 2.0 Millimeter | In distribution |
| 426-2002X | Shaft Length, 150 Centimeter | In distribution |
| 426-5015X | Balloon Diameter, 5.0 Millimeter | In distribution |
| 426-4012X | Balloon Length, 120 Millimeter | In distribution |
| 426-5010X | Balloon Length, 100 Millimeter | In distribution |
| 426-4010X | Balloon Length, 100 Millimeter | In distribution |
| 426-5028X | Shaft Length, 150 Centimeter | In distribution |
| 426-2028X | Balloon Length, 280 Millimeter | In distribution |
| 426-3004X | Balloon Length, 40 Millimeter | In distribution |
| 426-3008X | Shaft Length, 150 Centimeter | In distribution |
| 426-3510X | Balloon Length, 100 Millimeter | In distribution |
| 426-1508X | Balloon Length, 80 Millimeter | In distribution |
| 426-5022X | Balloon Diameter, 5.0 Millimeter | In distribution |
| 426-1201X | Balloon Diameter, 1.25 Millimeter | In distribution |
| 426-3528X | Balloon Length, 280 Millimeter | In distribution |
| 426-1502X | Balloon Diameter, 1.5 Millimeter | In distribution |
| 426-3015X | Balloon Diameter, 3.0 Millimeter | In distribution |
| 426-3502X | Balloon Length, 20 Millimeter | In distribution |
| 426-3010X | Balloon Diameter, 3.0 Millimeter | In distribution |
| 426-4028X | Balloon Diameter, 4.0 Millimeter | In distribution |
| 426-2522X | Balloon Diameter, 2.5 Millimeter | In distribution |
| 426-3022X | Shaft Length, 150 Centimeter | In distribution |
| 426-2508X | Balloon Diameter, 2.5 Millimeter | In distribution |
| 426-4004X | Shaft Length, 150 Centimeter | In distribution |
| 426-2528X | Balloon Diameter, 2.5 Millimeter | In distribution |
| 426-4015X | Balloon Diameter, 4.0 Millimeter | In distribution |
| 426-3508X | Shaft Length, 150 Centimeter | In distribution |
| 426-4002X | Balloon Diameter, 4.0 Millimeter | Withdrawn |
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 |
|---|---|
| K102035 | 2010-12-01 |
| K101361 | 2010-08-04 |
| K100490 | 2010-03-16 |
| K093139 | 2009-12-30 |
| K072947 | 2008-02-08 |
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.