Powerflex
Powerflexpro 5MM12CM 135
5manufacturers in China registered for this device type
70catalogue numbers in this listing
1510(k) clearance
6recalls 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 | Cordis US Corp., 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 |
| 510(k) | K112797 |
| Record published | 2016-08-01 |
| Record revised | 2025-09-05 (version 8) |
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 |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4400508X | In distribution | |
| 4400512X | In distribution | |
| 4400306X | In distribution | |
| 4400704X | In distribution | |
| 4400615S | In distribution | |
| 4400903S | In distribution | |
| 4400808X | In distribution | |
| 4401004S | In distribution | |
| 4400902S | In distribution | |
| 4400404X | In distribution | |
| 4400406X | In distribution | |
| 4401002X | In distribution | |
| 4400422X | In distribution | |
| 4400902X | In distribution | |
| 4400610S | In distribution | |
| 4400504S | In distribution | |
| 4400703S | In distribution | |
| 4400412X | In distribution | |
| 4400606X | In distribution | |
| 4400308S | In distribution | |
| 4400408X | In distribution | |
| 4401008S | In distribution | |
| 4400612S | In distribution | |
| 4401003S | In distribution | |
| 4400506X | In distribution | |
| 4401202S | In distribution | |
| 4401204X | In distribution | |
| 4400522S | In distribution | |
| 4400908X | In distribution | |
| 4400308X | In distribution | |
| 4400804X | In distribution | |
| 4400602X | In distribution | |
| 4400302S | In distribution | |
| 4400306S | In distribution | |
| 4400608X | In distribution | |
| 4401002S | In distribution | |
| 4400622S | In distribution | |
| 4400804S | In distribution | |
| 4401206S | In distribution | |
| 4400304X | In distribution | |
| 4400803S | In distribution | |
| 4400402S | In distribution | |
| 4400806X | In distribution | |
| 4400415S | In distribution | |
| 4400502X | In distribution | |
| 4400422S | In distribution | |
| 4400312S | In distribution | |
| 4400322S | In distribution | |
| 4400502S | In distribution | |
| 4400606S | In distribution | |
| 4400310X | In distribution | |
| 4401204S | In distribution | |
| 4401202X | In distribution | |
| 4400504X | In distribution | |
| 4400610X | In distribution | |
| 4400802X | In distribution | |
| 4400522X | In distribution | |
| 4400908S | In distribution | |
| 4401203S | In distribution | |
| 4400322X | In distribution | |
| 4400515X | In distribution | |
| 4400608S | In distribution | |
| 4400312X | In distribution | |
| 4400704S | In distribution | |
| 4400404S | In distribution | |
| 4400906S | In distribution | |
| 4400806S | In distribution | |
| 4400415X | In distribution | |
| 4400302X | In distribution | |
| 4401004X | 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 |
|---|---|
| K221832 | 2022-08-22 |
Recalls
5 of these are 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 |
|---|---|---|---|---|---|
| 2021-07-19 | Class II | Under Investigation by firm | The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon. | 8 units | 2023-02-16 |
| 2020-01-08 | Class II | Pending | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. | 89 units | 2023-01-13 |
| 2019-10-04 | Class II | Process control | Product was manufactured utilizing an expired inner body. | 21 units | 2020-12-14 |
| 2018-09-05 | Class II | Process control | Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). | 162 units total (74 units in USA) | 2021-02-11 |
| 2014-12-22 | Class II | Labeling design | One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized. | 120 | 2015-07-09 |
| 2005-05-11 | Not classified | Other | During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact. | 48 units | 2008-11-20 |
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.