Highlander
Highlander 014 PTA Balloon Dilatation Catheter 4.0mm x 100mm, 150cm Catheter
5manufacturers in China registered for this device type
140catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
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 | Bard Peripheral Vascular, 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, Complaint-file establishment, Manufacturer |
| Record published | 2023-03-02 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H4150410 | Catheter shaft length, 150 Centimeters | In distribution |
| H475215 | Balloon length, 150 Millimeters | In distribution |
| H4150312 | Balloon diameter, 3 Millimeters | In distribution |
| H4100312 | Balloon length, 120 Millimeters | In distribution |
| H41502H10 | Balloon diameter, 2.5 Millimeters | In distribution |
| H41003H6 | Balloon length, 60 Millimeters | In distribution |
| H415028 | Catheter shaft length, 150 Centimeters | In distribution |
| H413046 | Catheter shaft length, 130 Centimeters | In distribution |
| H4100412 | Catheter shaft length, 100 Centimeters | In distribution |
| H47548 | Balloon length, 80 Millimeters | In distribution |
| H41302H2 | Balloon length, 20 Millimeters | In distribution |
| H4753H12 | Balloon diameter, 3.5 Millimeters | In distribution |
| H413034 | Balloon length, 40 Millimeters | In distribution |
| H413028 | Balloon length, 80 Millimeters | In distribution |
| H410022 | Balloon length, 20 Millimeters | In distribution |
| H41503H6 | Balloon length, 60 Millimeters | In distribution |
| H4752H15 | Catheter shaft length, 75 Centimeters | In distribution |
| H41302H10 | Balloon diameter, 2.5 Millimeters | In distribution |
| H41302H8 | Catheter shaft length, 130 Centimeters | In distribution |
| H41503H10 | Balloon length, 100 Millimeters | In distribution |
| H41002H15 | Catheter shaft length, 100 Centimeters | In distribution |
| H4100210 | Balloon diameter, 2 Millimeters | In distribution |
| H4130212 | Balloon length, 120 Millimeters | In distribution |
| H41303H6 | Balloon diameter, 3.5 Millimeters | In distribution |
| H475410 | Balloon length, 100 Millimeters | In distribution |
| H47534 | Catheter shaft length, 75 Centimeters | In distribution |
| H410028 | Balloon length, 80 Millimeters | In distribution |
| H41503H15 | Balloon length, 150 Millimeters | In distribution |
| H41502H8 | Balloon diameter, 2.5 Millimeters | In distribution |
| H47532 | Catheter shaft length, 75 Centimeters | In distribution |
| H41003H4 | Balloon length, 40 Millimeters | In distribution |
| H41502H4 | Balloon length, 40 Millimeters | In distribution |
| H415034 | Balloon length, 40 Millimeters | In distribution |
| H415032 | Catheter shaft length, 150 Centimeters | In distribution |
| H4100215 | Balloon length, 150 Millimeters | In distribution |
| H41003H15 | Balloon diameter, 3.5 Millimeters | In distribution |
| H4753H4 | Balloon length, 40 Millimeters | In distribution |
| H41302H12 | Catheter shaft length, 130 Centimeters | In distribution |
| H413038 | Balloon length, 80 Millimeters | In distribution |
| H41002H2 | Balloon diameter, 2.5 Millimeters | In distribution |
| H47526 | Balloon length, 60 Millimeters | In distribution |
| H410046 | Catheter shaft length, 100 Centimeters | In distribution |
| H41002H10 | Balloon diameter, 2.5 Millimeters | In distribution |
| H4130415 | Balloon length, 150 Millimeters | In distribution |
| H4753H15 | Balloon diameter, 3.5 Millimeters | In distribution |
| H41002H8 | Catheter shaft length, 100 Centimeters | In distribution |
| H475415 | Catheter shaft length, 75 Centimeters | In distribution |
| H4100310 | Balloon diameter, 3 Millimeters | In distribution |
| H4100410 | Balloon length, 100 Millimeters | In distribution |
| H41503H12 | Catheter shaft length, 150 Centimeters | In distribution |
| H4752H8 | Catheter shaft length, 75 Centimeters | In distribution |
| H4130215 | Balloon length, 150 Millimeters | In distribution |
| H4753H8 | Balloon length, 80 Millimeters | In distribution |
| H47544 | Balloon diameter, 4 Millimeters | In distribution |
| H41303H8 | Catheter shaft length, 130 Centimeters | In distribution |
| H41002H6 | Catheter shaft length, 100 Centimeters | In distribution |
| H415038 | Balloon diameter, 3 Millimeters | In distribution |
| H47524 | Catheter shaft length, 75 Centimeters | In distribution |
| H413022 | Balloon length, 20 Millimeters | In distribution |
| H410038 | Catheter shaft length, 100 Centimeters | In distribution |
| H4130210 | Catheter shaft length, 130 Centimeters | In distribution |
| H413032 | Balloon diameter, 3 Millimeters | In distribution |
| H4753H2 | Balloon length, 20 Millimeters | In distribution |
| H4100415 | Balloon diameter, 4 Millimeters | In distribution |
| H4752H10 | Balloon length, 100 Millimeters | In distribution |
| H41503H8 | Balloon length, 80 Millimeters | In distribution |
| H41302H6 | Balloon diameter, 2.5 Millimeters | In distribution |
| H4752H6 | Balloon length, 60 Millimeters | In distribution |
| H4100212 | Balloon diameter, 2 Millimeters | In distribution |
| H41502H2 | Catheter shaft length, 150 Centimeters | In distribution |
| H413036 | Balloon diameter, 3 Millimeters | In distribution |
| H410048 | Balloon length, 80 Millimeters | In distribution |
| H41503H2 | Balloon length, 20 Millimeters | In distribution |
| H415048 | Balloon diameter, 4 Millimeters | In distribution |
| H41502H15 | Catheter shaft length, 150 Centimeters | In distribution |
| H4150215 | Balloon diameter, 2 Millimeters | In distribution |
| H41003H8 | Balloon diameter, 3.5 Millimeters | In distribution |
| H41303H4 | Balloon diameter, 3.5 Millimeters | In distribution |
| H4150415 | Balloon diameter, 4 Millimeters | In distribution |
| H41303H10 | Balloon length, 100 Millimeters | In distribution |
| H47542 | Balloon length, 20 Millimeters | In distribution |
| H4150310 | Catheter shaft length, 150 Centimeters | In distribution |
| H410032 | Catheter shaft length, 100 Centimeters | In distribution |
| H47538 | Catheter shaft length, 75 Centimeters | In distribution |
| H413048 | Balloon diameter, 4 Millimeters | In distribution |
| H415022 | Balloon diameter, 2 Millimeters | In distribution |
| H4150412 | Balloon length, 120 Millimeters | In distribution |
| H4130310 | Balloon diameter, 3 Millimeters | In distribution |
| H41303H2 | Catheter shaft length, 130 Centimeters | In distribution |
| H41003H10 | Balloon length, 100 Millimeters | In distribution |
| H41502H12 | Balloon diameter, 2.5 Millimeters | In distribution |
| H475412 | Catheter shaft length, 75 Centimeters | In distribution |
| H41003H2 | Balloon diameter, 3.5 Millimeters | In distribution |
| H413042 | Balloon diameter, 4 Millimeters | In distribution |
| H41003H12 | Balloon diameter, 3.5 Millimeters | In distribution |
| H475315 | Balloon length, 150 Millimeters | In distribution |
| H41002H4 | Balloon length, 40 Millimeters | In distribution |
| H475212 | Balloon length, 120 Millimeters | In distribution |
| H47536 | Balloon diameter, 3 Millimeters | In distribution |
| H4130315 | Balloon length, 150 Millimeters | In distribution |
| H4150210 | Balloon length, 100 Millimeters | In distribution |
| H41303H12 | Balloon diameter, 3.5 Millimeters | In distribution |
| H47522 | Balloon length, 20 Millimeters | In distribution |
| H4752H4 | Catheter shaft length, 75 Centimeters | In distribution |
| H4130312 | Balloon length, 120 Millimeters | In distribution |
| H415046 | Balloon diameter, 4 Millimeters | In distribution |
| H41503H4 | Balloon length, 40 Millimeters | In distribution |
| H41303H15 | Balloon diameter, 3.5 Millimeters | In distribution |
| H410024 | Balloon length, 40 Millimeters | In distribution |
| H47528 | Balloon length, 80 Millimeters | In distribution |
| H413026 | Balloon diameter, 2 Millimeters | In distribution |
| H4752H2 | Balloon length, 20 Millimeters | In distribution |
| H4150315 | Catheter shaft length, 150 Centimeters | In distribution |
| H47546 | Catheter shaft length, 75 Centimeters | In distribution |
| H4753H10 | Balloon diameter, 3.5 Millimeters | In distribution |
| H4753H6 | Balloon length, 60 Millimeters | In distribution |
| H410042 | Balloon diameter, 4 Millimeters | In distribution |
| H41002H12 | Balloon length, 120 Millimeters | In distribution |
| H413044 | Catheter shaft length, 130 Centimeters | In distribution |
| H415042 | Balloon diameter, 4 Millimeters | In distribution |
| H4150212 | Catheter shaft length, 150 Centimeters | In distribution |
| H475310 | Balloon diameter, 3 Millimeters | In distribution |
| H410036 | Catheter shaft length, 100 Centimeters | In distribution |
| H410034 | Balloon diameter, 3 Millimeters | In distribution |
| H410044 | Balloon diameter, 4 Millimeters | In distribution |
| H41302H4 | Catheter shaft length, 130 Centimeters | In distribution |
| H475210 | Balloon length, 100 Millimeters | In distribution |
| H41502H6 | Balloon length, 60 Millimeters | In distribution |
| H41302H15 | Catheter shaft length, 130 Centimeters | In distribution |
| H415044 | Catheter shaft length, 150 Centimeters | In distribution |
| H4130410 | Catheter shaft length, 130 Centimeters | In distribution |
| H415036 | Balloon diameter, 3 Millimeters | In distribution |
| H410026 | Balloon diameter, 2 Millimeters | In distribution |
| H415026 | Balloon length, 60 Millimeters | In distribution |
| H415024 | Catheter shaft length, 150 Centimeters | In distribution |
| H4100315 | Balloon diameter, 3 Millimeters | In distribution |
| H4752H12 | Catheter shaft length, 75 Centimeters | In distribution |
| H4130412 | Catheter shaft length, 130 Centimeters | In distribution |
| H475312 | Balloon length, 120 Millimeters | In distribution |
| H413024 | Catheter shaft length, 130 Centimeters | 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 |
|---|---|
| K192318 | 2019-10-03 |
| K142261 | 2014-09-24 |
| K131199 | 2013-05-30 |
| K120971 | 2012-04-19 |
| K120722 | 2012-04-19 |
| K120660 | 2012-03-15 |
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 |
|---|---|---|---|---|---|
| 2019-08-14 | Class II | Labeling mix-ups | The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation | 286 Units | 2021-02-26 |
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.