Advance Enforcer
Advance Enforcer 35 Focal Force PTA Balloon Catheter
3manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | PNO |
| Device type | Catheter, Percutaneous, Cutting/Scoring |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-12-09 |
| Record revised | 2019-08-09 (version 3) |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G35255 | In distribution | |
| G35254 | In distribution | |
| G35261 | In distribution | |
| G35258 | In distribution | |
| G35251 | In distribution | |
| G35249 | In distribution | |
| G35259 | In distribution | |
| G35253 | In distribution | |
| G35248 | In distribution | |
| G35250 | In distribution | |
| G35252 | In distribution | |
| G35257 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 168 |
| PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 120 |
| VascuTrak® | Bard Peripheral Vascular, Inc. | 109 |
| Ultrascore | Bard Peripheral Vascular, Inc. | 103 |
| Scoreflex PTA Scoring Balloon Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 58 |
| AngioSculpt® | Spectranetics Corp. | 51 |
| Aperta NSE™ PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | 38 |
| AngioSculpt OTW PTA Scoring Balloon Catheter | The Spectranetics Corp. | 25 |
| Serranator | Cagent Vascular | 18 |
| AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating | The Spectranetics Corp. | 13 |
| 2cm Peripheral Cutting Balloon® | Boston Scientific Corporation | 12 |
| Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | 11 |
Showing 12 of 16. All products under Catheter, Percutaneous, Cutting/Scoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141322 | 2015-03-27 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-05-24 | Class I | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and ba | 131 | 2019-10-31 |
| 2019-05-24 | Class I | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and ba | 73 | 2019-10-31 |
| 2019-05-24 | Class I | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and ba | 34 | 2019-10-31 |
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.