FOX
FOX sv PTA Catheter 2.5 mm x 120 mm x 150 cm
5manufacturers in China registered for this device type
61catalogue numbers in this listing
7510(k) clearances naming this product code
2recalls on this 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 | Abbott Vascular, 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, Exporter |
| Record published | 2016-08-05 |
| Record revised | 2020-03-30 (version 4) |
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 | Special storage condition: Store in cool, dry place. |
| Distribution end date | 2020-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82152-02 | In distribution | |
| 82373-02 | In distribution | |
| 82375-02 | In distribution | |
| 82377-02 | In distribution | |
| 83980-02 | Withdrawn | |
| 82174-02 | Withdrawn | |
| 83964-02 | Withdrawn | |
| 82160-02 | Withdrawn | |
| 83969-02 | Withdrawn | |
| 82148-02 | Withdrawn | |
| 83981-02 | Withdrawn | |
| 83973-02 | Withdrawn | |
| 83175-02 | Withdrawn | |
| 83972-02 | Withdrawn | |
| 83372-02 | Withdrawn | |
| 83976-02 | Withdrawn | |
| 83173-02 | Withdrawn | |
| 83171-02 | Withdrawn | |
| 82166-02 | Withdrawn | |
| 83966-02 | Withdrawn | |
| 83163-02 | Withdrawn | |
| 82176-02 | Withdrawn | |
| 82144-02 | Withdrawn | |
| 83145-02 | Withdrawn | |
| 83165-02 | Withdrawn | |
| 82172-02 | Withdrawn | |
| 83967-02 | Withdrawn | |
| 83378-02 | Withdrawn | |
| 82158-02 | Withdrawn | |
| 82146-02 | Withdrawn | |
| 83965-02 | Withdrawn | |
| 83153-02 | Withdrawn | |
| 83975-02 | Withdrawn | |
| 83157-02 | Withdrawn | |
| 82180-02 | Withdrawn | |
| 83978-02 | Withdrawn | |
| 83970-02 | Withdrawn | |
| 83968-02 | Withdrawn | |
| 83155-02 | Withdrawn | |
| 82162-02 | Withdrawn | |
| 83143-02 | Withdrawn | |
| 83161-02 | Withdrawn | |
| 82156-02 | Withdrawn | |
| 82184-02 | Withdrawn | |
| 83169-02 | Withdrawn | |
| 83159-02 | Withdrawn | |
| 83376-02 | Withdrawn | |
| 82168-02 | Withdrawn | |
| 83197-02 | Withdrawn | |
| 83984-02 | Withdrawn | |
| 82379-02 | Withdrawn | |
| 83149-02 | Withdrawn | |
| 83151-02 | Withdrawn | |
| 82150-02 | Withdrawn | |
| 83147-02 | Withdrawn | |
| 83979-02 | Withdrawn | |
| 83977-02 | Withdrawn | |
| 83974-02 | Withdrawn | |
| 82164-02 | Withdrawn | |
| 82170-02 | Withdrawn | |
| 83971-02 | 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 |
|---|---|
| K221057 | 2022-05-05 |
| K151317 | 2015-07-06 |
| K111899 | 2011-10-03 |
| K102705 | 2010-12-07 |
| K092286 | 2009-08-27 |
| K081417 | 2008-06-04 |
| K080925 | 2008-04-28 |
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 |
|---|---|---|---|---|---|
| 2012-08-20 | Class II | Process design | Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating. | 61,799 units | 2013-07-15 |
| 2009-05-06 | Not classified | Labeling mix-ups | Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0×15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging. | 26 | 2012-03-30 |
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.