Amphirion Plus
Amphirion Plus is an over-the-wire balloon catheter for peripheral angioplasty. Its coaxial shaft has a central guidewire lumen and a separate lumen for balloon inflation and deflation. Two…
Amphirion Plus is an over-the-wire balloon catheter for peripheral angioplasty. Its coaxial shaft has a central guidewire lumen and a separate lumen for balloon inflation and deflation. Two radiopaque marker bands beneath the balloon provide positioning references within the vessel.
It is intended to dilate iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal stenoses and obstructive lesions in native or synthetic arteriovenous dialysis fistulas. The catheter accepts guidewires up to 0.014 inches and is compatible with 4 Fr introducer sheaths.
Listed Item
Cath AHU020120102plusUS 02.00 L120UL1000
Shaft and Balloon Configuration
The catheter has a hydrophilic coating and usable lengths of 100 or 150 cm. Its proximal hub distinguishes the wire and balloon ports. The described modified range includes a 14 mm balloon length and a rated burst pressure of 20 atmospheres across balloon sizes.
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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K121265 |
| Record published | 2016-04-15 |
| 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 |
| Storage | Special storage condition: Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (such a |
| Sizes | Outer diameter 2 to 4 mm; length 14 to 120 mm |
| Distribution end date | 2018-10-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AHU020120102 | Outer Diameter 2.0 mm | Withdrawn |
| AHU035060102 | Length 60.0 mm | Withdrawn |
| AHU025014102 | Outer Diameter 2.5 mm | Withdrawn |
| AHU020060152 | Length 60.0 mm | Withdrawn |
| AHU035030152 | Length 30.0 mm | Withdrawn |
| AHU030060102 | Length 60.0 mm | Withdrawn |
| AHU035060152 | Outer Diameter 3.5 mm | Withdrawn |
| AHU025120102 | Outer Diameter 2.5 mm | Withdrawn |
| AHU020030152 | Outer Diameter 2.0 mm | Withdrawn |
| AHU025030152 | Length 30.0 mm | Withdrawn |
| AHU030080152 | Length 80.0 mm | Withdrawn |
| AHU025120152 | Length 120.0 mm | Withdrawn |
| AHU020060102 | Outer Diameter 2.0 mm | Withdrawn |
| AHU020080102 | Outer Diameter 2.0 mm | Withdrawn |
| AHU020120152 | Length 120.0 mm | Withdrawn |
| AHU030030102 | Length 30.0 mm | Withdrawn |
| AHU030060152 | Outer Diameter 3.0 mm | Withdrawn |
| AHU025080152 | Length 80.0 mm | Withdrawn |
| AHU040030152 | Length 30.0 mm | Withdrawn |
| AHU040014152 | Length 14.0 mm | Withdrawn |
| AHU030120152 | Outer Diameter 3.0 mm | Withdrawn |
| AHU030014102 | Length 14.0 mm | Withdrawn |
| AHU035014102 | Outer Diameter 3.5 mm | Withdrawn |
| AHU030080102 | Length 80.0 mm | Withdrawn |
| AHU020014152 | Length 14.0 mm | Withdrawn |
| AHU030030152 | Length 30.0 mm | Withdrawn |
| AHU035120152 | Length 120.0 mm | Withdrawn |
| AHU025060152 | Outer Diameter 2.5 mm | Withdrawn |
| AHU025060102 | Outer Diameter 2.5 mm | Withdrawn |
| AHU040030102 | Outer Diameter 4.0 mm | Withdrawn |
| AHU035080102 | Length 80.0 mm | Withdrawn |
| AHU020014102 | Outer Diameter 2.0 mm | Withdrawn |
| AHU025014152 | Outer Diameter 2.5 mm | Withdrawn |
| AHU035080152 | Outer Diameter 3.5 mm | Withdrawn |
| AHU025080102 | Outer Diameter 2.5 mm | Withdrawn |
| AHU035014152 | Outer Diameter 3.5 mm | Withdrawn |
| AHU025030102 | Outer Diameter 2.5 mm | Withdrawn |
| AHU035030102 | Outer Diameter 3.5 mm | Withdrawn |
| AHU040014102 | Outer Diameter 4.0 mm | Withdrawn |
| AHU020030102 | Length 30.0 mm | Withdrawn |
| AHU030014152 | Length 14.0 mm | Withdrawn |
| AHU030120102 | Outer Diameter 3.0 mm | Withdrawn |
| AHU035120102 | Outer Diameter 3.5 mm | Withdrawn |
| AHU020080152 | Length 80.0 mm | 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 |
|---|---|
| K213631 | 2021-12-15 |
| K121265 | 2012-05-22 |
| K103464 | 2010-12-22 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-11-10 | Class II | Process control | Medtronic identified an issue with specific models and lots of the PowerCross.018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an ou | 315 | 2017-08-02 |
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.