Axiom® PVC
Thoracic Catheter, Straight, PVC, With Trocar
7manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Axiom Medical, Inc., United States |
|---|---|
| FDA product code | GBS |
| Device type | Catheter, Ventricular, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Manufacturer |
| 510(k) | K863247 |
| Record published | 2018-09-23 |
| Record revised | 2024-01-03 (version 2) |
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 |
| Packaging | Box of 10, case of 10, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 522232 | 32 FR | In distribution |
| 500028 | 28 FR | In distribution |
| 500014 | 14 FR | In distribution |
| 522216 | 16 FR | In distribution |
| 511128 | 28 FR | In distribution |
| 511136 | 36 FR | In distribution |
| 511124 | 24 FR | In distribution |
| 500032 | 32 FR | In distribution |
| 522210 | 10 FR | In distribution |
| 511140 | 40 FR | In distribution |
| 522212 | 12 FR | In distribution |
| 500036 | 36 FR | In distribution |
| 511016 | 16 FR | In distribution |
| 500016 | 16 FR | In distribution |
| 522220 | 20 FR | In distribution |
| 500024 | 24 FR | In distribution |
| 500020 | 20 FR | In distribution |
| 522208 | 8 FR | In distribution |
| 522236 | 36 FR | In distribution |
| 511132 | 32 FR | In distribution |
| 522228 | 28 FR | In distribution |
| 522224 | 24 FR | In distribution |
| 500040 | 40 FR | In distribution |
| 511120 | 20 FR | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Axiom® Atraum™ With ClotStop® | Axiom Medical, Inc. | 69 |
| Silicone Thoracic Drain, S Type | Fortune Medical Instrument Corp. | 17 |
| Thoracic Drain | LivaNova USA, Inc. | 16 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 15 |
| Axiom® CWV Atraum™ With ClotStop® | Axiom Medical, Inc. | 14 |
| Argyle | Cardinal Health | 12 |
| Axiom® Dual-Sump Atraum™ With ClotStop® | Axiom Medical, Inc. | 9 |
| Axiom® Uni-Sump Atraum™ With ClotStop® | Axiom Medical, Inc. | 7 |
| Silicone Thoracic Drain, SF Type | Fortune Medical Instrument Corp. | 7 |
| Silicone Thoracic Drain, RF Type | Fortune Medical Instrument Corp. | 7 |
| Front1 Health Partners | Degania Silicone, Ltd. | 5 |
| Axiom® CWV Facial Atraum™ With ClotStop® | Axiom Medical, Inc. | 4 |
Showing 12 of 22. All products under Catheter, Ventricular, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K883887 | 1989-02-17 |
| K863247 | 1986-08-29 |
| K852241 | 1985-06-14 |
| K832416 | 1983-10-31 |
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.