Passeo-18
144 catalogue numbers from 4/40/130, listed by Biotronik, Inc., United States, under Catheter, Angioplasty, Peripheral, Transluminal. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
144catalogue numbers in this listing
10510(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 | Biotronik, Inc., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2026-06-01 (version 9) |
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 | Storage environment temperature 15 to 25 °C; Storage environment temperature 59 to 77 °F; Special storage condition: Keep dry Keep away from sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4/40/130 | Diameter: 4 mm | In distribution |
| 4/80/130 | Length: 80 mm | In distribution |
| 2/80/150 | Length: 80 mm | In distribution |
| 7/60/90 | Diameter: 7 mm | In distribution |
| 2/170/150 | Diameter: 2 mm | In distribution |
| 2.5/20/130 | Diameter: 2.5 mm | In distribution |
| 2.5/120/90 | Usable Length: 90 cm | In distribution |
| 6/150/90 | Usable Length: 90 cm | In distribution |
| 3/200/90 | Length: 200 mm | In distribution |
| 7/20/90 | Usable Length: 90 cm | In distribution |
| 2.5/220/130 | Length: 220 mm | In distribution |
| 2.5/200/130 | Usable Length: 130 cm | In distribution |
| 3/20/90 | Length: 20 mm | In distribution |
| 4/120/130 | Usable Length: 130 cm | In distribution |
| 3.5/120/90 | Diameter: 3.5 mm | In distribution |
| 3.5/220/130 | Diameter: 3.5 mm | In distribution |
| 3/220/130 | Usable Length: 130 cm | In distribution |
| 5/170/130 | Usable Length: 130 cm | In distribution |
| 3/220/90 | Diameter: 3 mm | In distribution |
| 7/200/90 | Diameter: 7 mm | In distribution |
| 3.5/200/90 | Length: 200 mm | In distribution |
| 3/170/90 | Length: 170 mm | In distribution |
| 3.5/80/130 | Usable Length: 130 cm | In distribution |
| 2.5/200/90 | Length: 200 mm | In distribution |
| 4/40/90 | Diameter: 4 mm | In distribution |
| 6/170/130 | Diameter: 6 mm | In distribution |
| 3.5/220/90 | Length: 220 mm | In distribution |
| 3.5/200/130 | Diameter: 3.5 mm | In distribution |
| 6/120/130 | Length: 120 mm | In distribution |
| 6/60/130 | Usable Length: 130 cm | In distribution |
| 7/220/90 | Length: 220 mm | In distribution |
| 5/40/130 | Diameter: 5 mm | In distribution |
| 6/220/90 | Length: 220 mm | In distribution |
| 6/80/130 | Usable Length: 130 cm | In distribution |
| 7/120/90 | Diameter: 7 mm | In distribution |
| 2.5/20/90 | Usable Length: 90 cm | In distribution |
| 3.5/80/90 | Diameter: 3.5 mm | In distribution |
| 2/120/90 | Usable Length: 90 cm | In distribution |
| 4/80/90 | Diameter: 4 mm | In distribution |
| 7/150/130 | Length: 150 mm | In distribution |
| 3/150/90 | Length: 150 mm | In distribution |
| 7/170/130 | Diameter: 7 mm | In distribution |
| 3.5/120/130 | Diameter: 3.5 mm | In distribution |
| 4/170/90 | Diameter: 4 mm | In distribution |
| 2/20/150 | Usable Length: 150 cm | In distribution |
| 4/60/90 | Diameter: 4 mm | In distribution |
| 2/120/150 | Diameter: 2 mm | In distribution |
| 2.5/80/130 | Diameter: 2.5 mm | In distribution |
| 7/60/130 | Length: 60 mm | In distribution |
| 2/40/90 | Diameter: 2 mm | In distribution |
| 3.5/150/130 | Length: 150 mm | In distribution |
| 2/200/90 | Diameter: 2 mm | In distribution |
| 2/200/150 | Length: 200 mm | In distribution |
| 7/80/90 | Diameter: 7 mm | In distribution |
| 2.5/120/130 | Usable Length: 130 cm | In distribution |
| 6/200/90 | Diameter: 6 mm | In distribution |
| 2.5/150/90 | Length: 150 mm | In distribution |
| 3/80/90 | Usable Length: 90 cm | In distribution |
| 6/80/90 | Usable Length: 90 cm | In distribution |
| 5/150/130 | Usable Length: 130 cm | In distribution |
| 2/20/90 | Diameter: 2 mm | In distribution |
| 3.5/150/90 | Diameter: 3.5 mm | In distribution |
| 6/40/90 | Usable Length: 90 cm | In distribution |
| 3/150/130 | Diameter: 3 mm | In distribution |
| 4/200/130 | Usable Length: 130 cm | In distribution |
| 3.5/60/130 | Length: 60 mm | In distribution |
| 2/170/90 | Usable Length: 90 cm | In distribution |
| 7/20/130 | Usable Length: 130 cm | In distribution |
| 3/20/130 | Usable Length: 130 cm | In distribution |
| 6/150/130 | Diameter: 6 mm | In distribution |
| 5/220/130 | Length: 220 mm | In distribution |
| 2/60/150 | Length: 60 mm | In distribution |
| 3.5/40/90 | Diameter: 3.5 mm | In distribution |
| 3/170/130 | Usable Length: 130 cm | In distribution |
| 2/40/150 | Usable Length: 150 cm | In distribution |
| 7/120/130 | Usable Length: 130 cm | In distribution |
| 2/220/90 | Length: 220 mm | In distribution |
| 3.5/40/130 | Diameter: 3.5 mm | In distribution |
| 3/60/130 | Length: 60 mm | In distribution |
| 7/40/90 | Length: 40 mm | In distribution |
| 5/200/130 | Usable Length: 130 cm | In distribution |
| 4/60/130 | Usable Length: 130 cm | In distribution |
| 5/80/90 | Usable Length: 90 cm | In distribution |
| 5/20/90 | Diameter: 5 mm | In distribution |
| 2.5/220/90 | Usable Length: 90 cm | In distribution |
| 3.5/20/130 | Usable Length: 130 cm | In distribution |
| 5/40/90 | Usable Length: 90 cm | In distribution |
| 5/60/90 | Length: 60 mm | In distribution |
| 7/80/130 | Usable Length: 130 cm | In distribution |
| 5/60/130 | Diameter: 5 mm | In distribution |
| 2.5/60/90 | Length: 60 mm | In distribution |
| 5/200/90 | Length: 200 mm | In distribution |
| 5/120/90 | Diameter: 5 mm | In distribution |
| 2.5/40/130 | Length: 40 mm | In distribution |
| 5/170/90 | Length: 170 mm | In distribution |
| 6/170/90 | Length: 170 mm | In distribution |
| 7/200/130 | Diameter: 7 mm | In distribution |
| 2/150/150 | Length: 150 mm | In distribution |
| 2.5/170/90 | Length: 170 mm | In distribution |
| 2.5/150/130 | Length: 150 mm | In distribution |
| 6/20/130 | Length: 20 mm | In distribution |
| 7/170/90 | Diameter: 7 mm | In distribution |
| 2.5/80/90 | Diameter: 2.5 mm | In distribution |
| 7/150/90 | Usable Length: 90 cm | In distribution |
| 5/80/130 | Usable Length: 130 cm | In distribution |
| 3.5/170/130 | Usable Length: 130 cm | In distribution |
| 2.5/170/130 | Length: 170 mm | In distribution |
| 2/150/90 | Usable Length: 90 cm | In distribution |
| 2.5/60/130 | Usable Length: 130 cm | In distribution |
| 4/150/130 | Length: 150 mm | In distribution |
| 2.5/40/90 | Diameter: 2.5 mm | In distribution |
| 4/220/90 | Diameter: 4 mm | In distribution |
| 2/60/90 | Usable Length: 90 cm | In distribution |
| 3/200/130 | Diameter: 3 mm | In distribution |
| 4/20/90 | Length: 20 mm | In distribution |
| 4/200/90 | Usable Length: 90 cm | In distribution |
| 6/60/90 | Length: 60 mm | In distribution |
| 4/20/130 | Usable Length: 130 cm | In distribution |
| 2/80/90 | Usable Length: 90 cm | In distribution |
| 3.5/60/90 | Diameter: 3.5 mm | In distribution |
| 3/40/90 | Diameter: 3 mm | In distribution |
| 3/120/130 | Usable Length: 130 cm | In distribution |
| 5/150/90 | Length: 150 mm | In distribution |
| 3/40/130 | Usable Length: 130 cm | In distribution |
| 3/120/90 | Usable Length: 90 cm | In distribution |
| 7/220/130 | Length: 220 mm | In distribution |
| 3/60/90 | Diameter: 3 mm | In distribution |
| 3.5/20/90 | Usable Length: 90 cm | In distribution |
| 5/120/130 | Diameter: 5 mm | In distribution |
| 4/170/130 | Usable Length: 130 cm | In distribution |
| 4/120/90 | Length: 120 mm | In distribution |
| 6/40/130 | Diameter: 6 mm | In distribution |
| 5/20/130 | Usable Length: 130 cm | In distribution |
| 6/120/90 | Diameter: 6 mm | In distribution |
| 4/150/90 | Usable Length: 90 cm | In distribution |
| 6/20/90 | Usable Length: 90 cm | In distribution |
| 7/40/130 | Usable Length: 130 cm | In distribution |
| 6/200/130 | Diameter: 6 mm | In distribution |
| 2/220/150 | Diameter: 2 mm | In distribution |
| 5/220/90 | Length: 220 mm | In distribution |
| 4/220/130 | Usable Length: 130 cm | In distribution |
| 3/80/130 | Length: 80 mm | In distribution |
| 6/220/130 | Length: 220 mm | In distribution |
| 3.5/170/90 | Diameter: 3.5 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 |
|---|---|
| K250706 | 2025-04-04 |
| K241711 | 2024-07-11 |
| K222065 | 2023-02-16 |
| K214038 | 2022-07-06 |
| K151744 | 2015-10-08 |
| K152240 | 2015-10-08 |
| K142379 | 2014-12-05 |
| K130161 | 2013-04-23 |
| K072765 | 2007-12-12 |
| K052757 | 2005-10-28 |
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.