Sublime™ Radial Access 018 RX PTA Dilatation Catheter
018 Radial RX PTA, 5Fr, 3.5 mm x 150 mm, 220 cm
5manufacturers in China registered for this device type
54catalogue numbers in this listing
6510(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 | Creagh Medical Ltd., Ireland |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K211044 |
| Record published | 2021-10-20 |
| Record revised | 2025-03-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 220 cm; balloon diameter 2 to 6 mm; balloon length 20 to 220 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SRA-DC18-35040 | Length 220 cm | In distribution |
| SRA-DC18-35150 | Length 220 cm | In distribution |
| SRA-DC18-20150 | Length 220 cm | In distribution |
| SRA-DC18-60080 | Length 220 cm | In distribution |
| SRA-DC18-20080 | Length 220 cm | In distribution |
| SRA-DC18-50120 | Length 220 cm | In distribution |
| SRA-DC18-30220 | Length 220 cm | In distribution |
| SRA-DC18-40220 | Length 220 cm | In distribution |
| SRA-DC18-50100 | Length 220 cm | In distribution |
| SRA-DC18-40080 | Length 220 cm | In distribution |
| SRA-DC18-60060 | Length 220 cm | In distribution |
| SRA-DC18-25120 | Length 220 cm | In distribution |
| SRA-DC18-25100 | Length 220 cm | In distribution |
| SRA-DC18-40120 | Length 220 cm | In distribution |
| SRA-DC18-50060 | Length 220 cm | In distribution |
| SRA-DC18-25220 | Length 220 cm | In distribution |
| SRA-DC18-40040 | Length 220 cm | In distribution |
| SRA-DC18-35100 | Length 220 cm | In distribution |
| SRA-DC18-60020 | Length 220 cm | In distribution |
| SRA-DC18-20220 | Length 220 cm | In distribution |
| SRA-DC18-40150 | Length 220 cm | In distribution |
| SRA-DC18-30080 | Length 220 cm | In distribution |
| SRA-DC18-20060 | Length 220 cm | In distribution |
| SRA-DC18-20020 | Length 220 cm | In distribution |
| SRA-DC18-60100 | Length 220 cm | In distribution |
| SRA-DC18-40020 | Length 220 cm | In distribution |
| SRA-DC18-60150 | Length 220 cm | In distribution |
| SRA-DC18-50080 | Length 220 cm | In distribution |
| SRA-DC18-30040 | Length 220 cm | In distribution |
| SRA-DC18-40060 | Length 220 cm | In distribution |
| SRA-DC18-20120 | Length 220 cm | In distribution |
| SRA-DC18-25040 | Length 220 cm | In distribution |
| SRA-DC18-30020 | Length 220 cm | In distribution |
| SRA-DC18-25020 | Length 220 cm | In distribution |
| SRA-DC18-60120 | Length 220 cm | In distribution |
| SRA-DC18-35120 | Length 220 cm | In distribution |
| SRA-DC18-50150 | Length 220 cm | In distribution |
| SRA-DC18-50020 | Length 220 cm | In distribution |
| SRA-DC18-20100 | Length 220 cm | In distribution |
| SRA-DC18-30100 | Length 220 cm | In distribution |
| SRA-DC18-35220 | Length 220 cm | In distribution |
| SRA-DC18-40100 | Length 220 cm | In distribution |
| SRA-DC18-20040 | Length 220 cm | In distribution |
| SRA-DC18-25150 | Length 220 cm | In distribution |
| SRA-DC18-50040 | Length 220 cm | In distribution |
| SRA-DC18-60040 | Length 220 cm | In distribution |
| SRA-DC18-30150 | Length 220 cm | In distribution |
| SRA-DC18-25080 | Length 220 cm | In distribution |
| SRA-DC18-25060 | Length 220 cm | In distribution |
| SRA-DC18-35060 | Length 220 cm | In distribution |
| SRA-DC18-30060 | Length 220 cm | In distribution |
| SRA-DC18-35020 | Length 220 cm | In distribution |
| SRA-DC18-35080 | Length 220 cm | In distribution |
| SRA-DC18-30120 | Length 220 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 |
|---|---|
| K230191 | 2023-03-22 |
| K200700 | 2020-05-14 |
| K180007 | 2018-04-19 |
| K171251 | 2017-09-08 |
| K113468 | 2011-12-20 |
| K102645 | 2010-12-10 |
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.