SABER.014 PTA Dilatation Catheter
PTA, OTW, 2.5 x 250, 150cm
5manufacturers in China registered for this device type
17catalogue numbers in this listing
30510(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 | Cordis Corp., United States |
|---|---|
| FDA product code | LIT |
| Device type | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K221832 |
| Record published | 2023-07-05 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47020250S | In distribution | |
| 47025300S | In distribution | |
| 47025250M | In distribution | |
| 47025300M | In distribution | |
| 47012015M | In distribution | |
| 47015100S | In distribution | |
| 47015100M | In distribution | |
| 47030250M | In distribution | |
| 47040080S | In distribution | |
| 47030040M | In distribution | |
| 47035040S | In distribution | |
| 47040300M | In distribution | |
| 47035250M | In distribution | |
| 47050250S | In distribution | |
| 47035080S | In distribution | |
| 47030120S | In distribution | |
| 47050300S | 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 |
|---|---|
| K210626 | 2021-04-23 |
| K201377 | 2020-10-09 |
| K201333 | 2020-09-11 |
| K133843 | 2014-06-27 |
| K121442 | 2012-06-14 |
| K112797 | 2012-05-04 |
| K050645 | 2005-04-01 |
| K003159 | 2000-10-30 |
| K992825 | 1999-09-15 |
| K991811 | 1999-06-15 |
| K981407 | 1998-05-20 |
| K971516 | 1997-07-23 |
| K971579 | 1997-07-18 |
| K971448 | 1997-07-03 |
| K971010 | 1997-06-18 |
| K970620 | 1997-05-06 |
| K970299 | 1997-04-24 |
| K963000 | 1997-02-20 |
| K962945 | 1996-10-23 |
| K955886 | 1996-03-11 |
| K950119 | 1995-05-17 |
| K946052 | 1995-03-03 |
| K942094 | 1994-11-01 |
| K940868 | 1994-07-12 |
| K933236 | 1993-12-27 |
| K905698 | 1991-07-09 |
| K894899 | 1990-01-26 |
| K880612 | 1988-07-28 |
| K844913 | 1985-08-20 |
| K812168 | 1981-08-31 |
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.