USE® 0.035″ PTA OTW Catheter
USE® 0.035" PTA OTW Catheter, 10.00x20mm /Shaft length 130cm
5manufacturers in China registered for this device type
80catalogue numbers in this listing
9510(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 | Natec Medical Ltd, MU |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-10-07 |
| Record revised | 2019-08-09 (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 |
| Storage | Special storage condition: keep dry and Keep away from sunlight; Handling environment temperature 15 to 40 °C |
| Sizes | Outer diameter 5 to 10 mm; length 20 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| USE3510_00-40A | Outer Diameter 10.00 mm | In distribution |
| USE358_00-80A | Outer Diameter 8.00 mm | In distribution |
| USE3510_00-80A | Outer Diameter 10.00 mm | In distribution |
| USE358_00-40B | Outer Diameter 8.00 mm | In distribution |
| USE359_00-20A | Length 20.0 mm | In distribution |
| USE357_00-80B | Outer Diameter 7.00 mm | In distribution |
| USE356_00-120A | Outer Diameter 6.00 mm | In distribution |
| USE356_00-20B | Length 20.0 mm | In distribution |
| USE358_00-20B | Length 20.0 mm | In distribution |
| USE355_00-100A | Length 100.0 mm | In distribution |
| USE356_00-80B | Outer Diameter 6.00 mm | In distribution |
| USE357_00-20A | Length 20.0 mm | In distribution |
| USE3510_00-20B | Length 20.0 mm | In distribution |
| USE355_00-150B | Length 150.0 mm | In distribution |
| USE357_00-60A | Length 60.0 mm | In distribution |
| USE356_00-20A | Length 20.0 mm | In distribution |
| USE3510_00-20A | Length 20.0 mm | In distribution |
| USE359_00-80A | Outer Diameter 9.00 mm | In distribution |
| USE359_00-40B | Outer Diameter 9.00 mm | In distribution |
| USE358_00-120A | Outer Diameter 8.00 mm | In distribution |
| USE356_00-100A | Length 100.0 mm | In distribution |
| USE357_00-100A | Length 100.0 mm | In distribution |
| USE3510_00-60B | Length 60.0 mm | In distribution |
| USE358_00-60B | Length 60.0 mm | In distribution |
| USE355_00-100B | Length 100.0 mm | In distribution |
| USE357_00-80A | Outer Diameter 7.00 mm | In distribution |
| USE355_00-120A | Outer Diameter 5.00 mm | In distribution |
| USE3510_00-60A | Length 60.0 mm | In distribution |
| USE355_00-120B | Outer Diameter 5.00 mm | In distribution |
| USE355_00-60B | Length 60.0 mm | In distribution |
| USE357_00-100B | Length 100.0 mm | In distribution |
| USE355_00-150A | Length 150.0 mm | In distribution |
| USE357_00-60B | Length 60.0 mm | In distribution |
| USE356_00-60A | Length 60.0 mm | In distribution |
| USE357_00-150B | Length 150.0 mm | In distribution |
| USE356_00-200A | Outer Diameter 6.00 mm | In distribution |
| USE359_00-60B | Length 60.0 mm | In distribution |
| USE355_00-20A | Length 20.0 mm | In distribution |
| USE359_00-40A | Outer Diameter 9.00 mm | In distribution |
| USE356_00-40B | Outer Diameter 6.00 mm | In distribution |
| USE359_00-80B | Outer Diameter 9.00 mm | In distribution |
| USE355_00-80A | Outer Diameter 5.00 mm | In distribution |
| USE358_00-200A | Outer Diameter 8.00 mm | In distribution |
| USE355_00-20B | Length 20.0 mm | In distribution |
| USE357_00-150A | Length 150.0 mm | In distribution |
| USE356_00-150B | Length 150.0 mm | In distribution |
| USE358_00-100A | Length 100.0 mm | In distribution |
| USE355_00-200B | Outer Diameter 5.00 mm | In distribution |
| USE3510_00-80B | Outer Diameter 10.00 mm | In distribution |
| USE355_00-60A | Length 60.0 mm | In distribution |
| USE357_00-200B | Outer Diameter 7.00 mm | In distribution |
| USE358_00-100B | Length 100.0 mm | In distribution |
| USE355_00-40A | Outer Diameter 5.00 mm | In distribution |
| USE358_00-60A | Length 60.0 mm | In distribution |
| USE356_00-100B | Length 100.0 mm | In distribution |
| USE357_00-40B | Outer Diameter 7.00 mm | In distribution |
| USE357_00-120B | Outer Diameter 7.00 mm | In distribution |
| USE358_00-120B | Outer Diameter 8.00 mm | In distribution |
| USE358_00-200B | Outer Diameter 8.00 mm | In distribution |
| USE357_00-200A | Outer Diameter 7.00 mm | In distribution |
| USE3510_00-40B | Outer Diameter 10.00 mm | In distribution |
| USE358_00-80B | Outer Diameter 8.00 mm | In distribution |
| USE359_00-20B | Length 20.0 mm | In distribution |
| USE355_00-40B | Outer Diameter 5.00 mm | In distribution |
| USE359_00-60A | Length 60.0 mm | In distribution |
| USE357_00-20B | Length 20.0 mm | In distribution |
| USE358_00-40A | Outer Diameter 8.00 mm | In distribution |
| USE357_00-120A | Outer Diameter 7.00 mm | In distribution |
| USE356_00-200B | Outer Diameter 6.00 mm | In distribution |
| USE358_00-20A | Length 20.0 mm | In distribution |
| USE357_00-40A | Outer Diameter 7.00 mm | In distribution |
| USE358_00-150B | Length 150.0 mm | In distribution |
| USE355_00-200A | Outer Diameter 5.00 mm | In distribution |
| USE356_00-150A | Length 150.0 mm | In distribution |
| USE356_00-120B | Outer Diameter 6.00 mm | In distribution |
| USE355_00-80B | Outer Diameter 5.00 mm | In distribution |
| USE356_00-60B | Length 60.0 mm | In distribution |
| USE358_00-150A | Length 150.0 mm | In distribution |
| USE356_00-40A | Outer Diameter 6.00 mm | In distribution |
| USE356_00-80A | Outer Diameter 6.00 mm | 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 |
|---|---|
| K251915 | 2025-12-18 |
| K241040 | 2024-12-18 |
| K220410 | 2022-06-29 |
| K152230 | 2015-09-03 |
| K143041 | 2015-06-04 |
| K143036 | 2015-03-30 |
| K142459 | 2015-02-03 |
| K112513 | 2011-12-09 |
| K103354 | 2011-02-23 |
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.