ELM HP PTA
ELM HP PTA 6mm x 100mm x 75cm
5manufacturers in China registered for this device type
42catalogue numbers in this listing
6510(k) clearances naming this product 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 | Creagh Medical Ltd., Ireland |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K102645 |
| Record published | 2016-09-22 |
| Record revised | 2025-02-17 (version 5) |
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 |
| Sizes | Length 20 to 100 mm; outer diameter 3 to 12 mm |
| Distribution end date | 2025-02-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELM640L | Length 40 mm | Withdrawn |
| ELM860S | Length 60 mm | Withdrawn |
| ELM6100L | Length 100 mm | Withdrawn |
| ELM620L | Length 20 mm | Withdrawn |
| ELM640S | Length 40 mm | Withdrawn |
| ELM820L | Length 20 mm | Withdrawn |
| ELM880L | Length 80 mm | Withdrawn |
| ELM540L | Length 40 mm | Withdrawn |
| ELM740S | Length 40 mm | Withdrawn |
| ELM560S | Length 60 mm | Withdrawn |
| ELM420S | Length 20 mm | Withdrawn |
| ELM6100S | Length 100 mm | Withdrawn |
| ELM440L | Length 40 mm | Withdrawn |
| ELM420L | Length 20 mm | Withdrawn |
| ELM820S | Length 20 mm | Withdrawn |
| ELM560L | Length 60 mm | Withdrawn |
| ELM540S | Length 40 mm | Withdrawn |
| ELM440S | Length 40 mm | Withdrawn |
| ELM1040S | Length 40 mm | Withdrawn |
| ELM840L | Length 40 mm | Withdrawn |
| ELM760L | Length 60 mm | Withdrawn |
| ELM840S | Length 40 mm | Withdrawn |
| ELM940S | Length 40 mm | Withdrawn |
| ELM860L | Length 60 mm | Withdrawn |
| ELM520S | Length 20 mm | Withdrawn |
| ELM720S | Length 20 mm | Withdrawn |
| ELM340S | Length 40 mm | Withdrawn |
| ELM520L | Length 20 mm | Withdrawn |
| ELM7100L | Length 100 mm | Withdrawn |
| ELM660L | Length 60 mm | Withdrawn |
| ELM1240S | Length 40 mm | Withdrawn |
| ELM340L | Length 40 mm | Withdrawn |
| ELM1040L | Length 40 mm | Withdrawn |
| ELM7100S | Length 100 mm | Withdrawn |
| ELM1240L | Length 40 mm | Withdrawn |
| ELM660S | Length 60 mm | Withdrawn |
| ELM880S | Length 80 mm | Withdrawn |
| ELM720L | Length 20 mm | Withdrawn |
| ELM620S | Length 20 mm | Withdrawn |
| ELM740L | Length 40 mm | Withdrawn |
| ELM760S | Length 60 mm | Withdrawn |
| ELM940L | Length 40 mm | 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 |
|---|---|
| K230191 | 2023-03-22 |
| K200700 | 2020-05-14 |
| K180007 | 2018-04-19 |
| K171251 | 2017-09-08 |
| K113468 | 2011-12-20 |
| K102645 | 2010-12-10 |
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.