Saber.035
SABER.035 is a peripheral angioplasty catheter with an inflatable balloon at its distal end. Radiopaque bands mark the balloon’s working length for placement under fluoroscopy, and a…
SABER.035 is a peripheral angioplasty catheter with an inflatable balloon at its distal end. Radiopaque bands mark the balloon’s working length for placement under fluoroscopy, and a tapered tip helps it enter peripheral arteries and cross narrowed segments.
A proximal hub separates the guidewire port from the balloon inflation port. The inflation lumen carries diluted contrast medium to the balloon. The family is available in different balloon diameters and lengths.
Listed Item
SABER.035 PTA Dilation Catheter 10mm x 100mm x 135cm
Connections and Supply
The catheter is designed for a standard 0.035-inch guidewire and 5, 6 or 7 French catheter sheath introducers. Compatibility depends on the selected configuration. It is supplied ethylene oxide sterilized and is intended for single use.
5manufacturers in China registered for this device type
174catalogue 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) | K210626 |
| Record published | 2021-12-22 |
| Record revised | 2024-06-28 (version 5) |
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 |
|---|---|---|
| 48006015N | In distribution | |
| 48004030R | In distribution | |
| 48003002N | In distribution | |
| 48012004N | In distribution | |
| 48006020N | In distribution | |
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| 48003020N | In distribution | |
| 48009006N | In distribution | |
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| 48007010P | In distribution | |
| 48008002R | In distribution | |
| 48008004N | In distribution | |
| 48003010R | In distribution | |
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| 48007008P | In distribution | |
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| 48004025N | In distribution | |
| 48004012N | In distribution | |
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| 48003006N | In distribution | |
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| 48009004N | In distribution | |
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| 48009002N | In distribution | |
| 48010006N | In distribution | |
| 48009004P | In distribution | |
| 48006030N | In distribution | |
| 48007025R | In distribution | |
| 48009006R | In distribution | |
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| 48004006N | In distribution | |
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| 48004006P | In distribution | |
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| 48004006R | In distribution | |
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| 48007010R | In distribution | |
| 48007008R | In distribution | |
| 48005015R | In distribution | |
| 48003030N | In distribution | |
| 48004004N | In distribution | |
| 48005002N | In distribution | |
| 48009008R | In distribution | |
| 48005030N | In distribution | |
| 48007008N | In distribution | |
| 48007006R | In distribution | |
| 48005008N | In distribution | |
| 48009002R | In distribution | |
| 48007004N | In distribution | |
| 48007010N | In distribution | |
| 48003006R | In distribution | |
| 48007006N | In distribution | |
| 48003020R | In distribution | |
| 48012002R | In distribution | |
| 48007030R | In distribution | |
| 48003010P | In distribution | |
| 48003025R | In distribution | |
| 48012004R | In distribution | |
| 48007004R | In distribution | |
| 48008002N | In distribution | |
| 48004008P | In distribution | |
| 48005015N | In distribution | |
| 48010002N | In distribution | |
| 48004015R | In distribution | |
| 48008008R | In distribution | |
| 48006008N | In distribution | |
| 48006025N | In distribution | |
| 48007002N | In distribution | |
| 48012004P | In distribution | |
| 48008006R | In distribution | |
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| 48009010R | In distribution | |
| 48006006N | In distribution | |
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| 48006030R | In distribution | |
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| 48010004N | In distribution | |
| 48006010R | In distribution | |
| 48003008N | In distribution | |
| 48003002R | In distribution | |
| 48009004R | In distribution | |
| 48007002R | In distribution | |
| 48006004N | In distribution | |
| 48004002R | In distribution | |
| 48008006N | In distribution | |
| 48007020R | In distribution | |
| 48006004P | In distribution | |
| 48005012P | In distribution | |
| 48004004P | In distribution | |
| 48003004N | In distribution | |
| 48010010N | In distribution | |
| 48003008R | In distribution | |
| 48004008N | In distribution | |
| 48005004R | In distribution | |
| 48008008P | In distribution | |
| 48006008P | In distribution | |
| 48010006R | In distribution | |
| 48004030N | In distribution | |
| 48005020N | In distribution | |
| 48006002N | In distribution | |
| 48003012N | In distribution | |
| 48003010N | In distribution | |
| 48006006R | In distribution | |
| 48009010N | In distribution | |
| 48005002R | In distribution | |
| 48010008R | In distribution | |
| 48006008R | In distribution | |
| 48006015R | In distribution | |
| 48004025R | In distribution | |
| 48004004R | In distribution | |
| 48006010P | 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.