Saber
Saber 2.5MM30CM 150
5manufacturers in China registered for this device type
91catalogue 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) | K133843 |
| Record published | 2016-08-01 |
| Record revised | 2024-07-25 (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 |
| Distribution end date | 2024-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 48008002X | In distribution | |
| 48002530X | In distribution | |
| 48003510S | In distribution | |
| 48003025S | In distribution | |
| 48009004S | In distribution | |
| 48002504X | In distribution | |
| 48002520S | In distribution | |
| 48003508X | In distribution | |
| 48002015S | In distribution | |
| 48003515S | In distribution | |
| 48005004X | In distribution | |
| 48002008S | In distribution | |
| 48002520X | In distribution | |
| 48005015X | In distribution | |
| 48006002S | In distribution | |
| 48006025X | In distribution | |
| 48003020X | In distribution | |
| 48004030S | In distribution | |
| 48002508X | In distribution | |
| 48003506X | In distribution | |
| 48008006S | In distribution | |
| 48004010S | In distribution | |
| 48003008X | In distribution | |
| 48004006X | In distribution | |
| 48004006S | In distribution | |
| 48003502S | In distribution | |
| 48002025S | In distribution | |
| 48002010S | In distribution | |
| 48005003S | In distribution | |
| 48009003S | In distribution | |
| 48008010S | In distribution | |
| 48008006X | In distribution | |
| 48006015X | In distribution | |
| 48003530S | In distribution | |
| 48004003X | In distribution | |
| 48010003S | In distribution | |
| 48005020X | In distribution | |
| 48002503X | In distribution | |
| 48007010S | In distribution | |
| 48003525S | In distribution | |
| 48002008X | In distribution | |
| 48004008S | In distribution | |
| 48002020S | In distribution | |
| 48002530S | In distribution | |
| 48003515X | In distribution | |
| 48004020X | In distribution | |
| 48002515S | In distribution | |
| 48005006X | In distribution | |
| 48008004S | In distribution | |
| 48005008S | In distribution | |
| 48003030S | In distribution | |
| 48002002X | In distribution | |
| 48002002S | In distribution | |
| 48005030S | In distribution | |
| 48007003S | In distribution | |
| 48002015X | In distribution | |
| 48005002S | In distribution | |
| 48003525X | In distribution | |
| 48007006X | In distribution | |
| 48007008S | In distribution | |
| 48004008X | In distribution | |
| 48006030S | In distribution | |
| 48002510X | In distribution | |
| 48008002S | In distribution | |
| 48003003X | In distribution | |
| 48002030S | In distribution | |
| 48003002X | In distribution | |
| 48009006S | In distribution | |
| 48009002S | In distribution | |
| 48003504X | In distribution | |
| 48007006S | In distribution | |
| 48006020X | In distribution | |
| 48003504S | In distribution | |
| 48005003X | In distribution | |
| 48009003X | In distribution | |
| 48007008X | In distribution | |
| 48005020S | In distribution | |
| 48003502X | In distribution | |
| 48004015S | In distribution | |
| 48005025S | In distribution | |
| 48005008X | In distribution | |
| 48002006S | In distribution | |
| 48005025X | In distribution | |
| 48006015S | In distribution | |
| 48007004S | In distribution | |
| 48009010S | Withdrawn | |
| 48008008S | Withdrawn | |
| 48008003X | Withdrawn | |
| 48003506S | Withdrawn | |
| 48010006S | Withdrawn | |
| 48009008S | 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 |
|---|---|
| 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 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 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 |
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.