Arrow
014 Arrow GPSCath, 2.5x150mm, 150cm NA
5manufacturers in China registered for this device type
63catalogue numbers in this listing
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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142300 |
| Record published | 2017-04-20 |
| Record revised | 2025-11-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Keep away from sunlight |
| Packaging | Box, case of 10, case of 5, case of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN000406 | In distribution | |
| IPN000421 | In distribution | |
| IPN001038 | In distribution | |
| IPN046991 | In distribution | |
| IPN000419 | In distribution | |
| IPN000409 | In distribution | |
| IPN001017 | In distribution | |
| IPN001026 | In distribution | |
| IPN000426 | In distribution | |
| IPN001037 | In distribution | |
| IPN000418 | In distribution | |
| IPN001014 | In distribution | |
| IPN000408 | In distribution | |
| IPN000404 | In distribution | |
| IPN001031 | In distribution | |
| IPN001027 | In distribution | |
| IPN000424 | In distribution | |
| IPN000405 | In distribution | |
| IPN001025 | In distribution | |
| IPN001022 | In distribution | |
| IPN001036 | In distribution | |
| IPN001016 | In distribution | |
| IPN001029 | In distribution | |
| IPN001035 | In distribution | |
| IPN001021 | In distribution | |
| IPN001020 | In distribution | |
| IPN000410 | In distribution | |
| IPN000403 | In distribution | |
| IPN001034 | In distribution | |
| IPN001013 | In distribution | |
| IPN001019 | In distribution | |
| IPN001024 | In distribution | |
| IPN000425 | In distribution | |
| IPN000430 | In distribution | |
| IPN000423 | In distribution | |
| IPN001032 | In distribution | |
| IPN001011 | In distribution | |
| IPN037316 | In distribution | |
| IPN000414 | In distribution | |
| IPN000427 | In distribution | |
| IPN000417 | In distribution | |
| IPN001012 | In distribution | |
| IPN001023 | In distribution | |
| IPN001015 | In distribution | |
| IPN000407 | In distribution | |
| IPN000411 | In distribution | |
| IPN001030 | In distribution | |
| IPN000422 | In distribution | |
| IPN000432 | In distribution | |
| IPN000416 | In distribution | |
| IPN000412 | In distribution | |
| IPN000420 | In distribution | |
| IPN000429 | In distribution | |
| IPN000413 | In distribution | |
| IPN001033 | In distribution | |
| IPN001018 | In distribution | |
| IPN000433 | In distribution | |
| IPN000431 | In distribution | |
| IPN000415 | In distribution | |
| IPN000428 | In distribution | |
| IPN001010 | In distribution | |
| IPN036330 | In distribution | |
| IPN001028 | 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
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.