Atlas®
Atlas® PTA Balloon Dilatation Catheter 16 mm x 40 mm, 120 cm Catheter
5manufacturers in China registered for this device type
22catalogue 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 | 2016-06-03 |
| Record revised | 2024-06-28 (version 4) |
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 |
|---|---|---|
| AT75182 | Balloon Length, 20 Millimeter | In distribution |
| AT75122 | Balloon Length, 20 Millimeter | In distribution |
| AT75262 | Shaft Length, 75 Centimeter | In distribution |
| AT75244 | Shaft Length, 75 Centimeter | In distribution |
| AT75124 | Balloon Diameter, 12 Millimeter | In distribution |
| AT120164 | Balloon Length, 40 Millimeter | In distribution |
| AT120142 | Balloon Length, 20 Millimeter | In distribution |
| AT75186 | Shaft Length, 75 Centimeter | In distribution |
| AT120144 | Balloon Length, 40 Millimeter | In distribution |
| AT120262 | Balloon Length, 20 Millimeter | In distribution |
| AT120122 | Balloon Length, 20 Millimeter | In distribution |
| AT120242 | Balloon Length, 20 Millimeter | In distribution |
| AT120146 | Balloon Diameter, 14 Millimeter | In distribution |
| AT120186 | Balloon Diameter, 18 Millimeter | In distribution |
| AT75166 | Balloon Diameter, 16 Millimeter | In distribution |
| AT75202 | Shaft Length, 75 Centimeter | In distribution |
| AT120166 | Shaft Length, 120 Centimeter | In distribution |
| AT75264 | Shaft Length, 75 Centimeter | In distribution |
| AT120244 | Balloon Length, 40 Millimeter | In distribution |
| AT120222 | Balloon Length, 20 Millimeter | In distribution |
| AT120202 | Balloon Length, 20 Millimeter | In distribution |
| AT120182 | Balloon Diameter, 18 Millimeter | 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.