Vaxcel
Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Intermediate Introducer Kit
5manufacturers in China registered for this device type
48catalogue numbers in this listing
16510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Record published | 2015-09-14 |
| Record revised | 2021-02-19 (version 4) |
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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Box of 5, box of 4, box of 3 |
| Sizes | Catheter gauge 3 to 6 Fr; length 55 to 60 cm; outer diameter 1.02 to 1.95 mm; needle gauge 15 to 21 G |
| Distribution end date | 2021-11-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45456 | Catheter Gauge 4 Fr | Withdrawn |
| 60M212081 | Single Lumen | Withdrawn |
| 60M030703 | Catheter Gauge 5 Fr | Withdrawn |
| 60M192792 | Dual Lumen | Withdrawn |
| 60M184114 | Catheter Gauge 4 Fr | Withdrawn |
| 45463 | Needle Gauge 21 G | Withdrawn |
| 60M195332 | Single Lumen | Withdrawn |
| 60M701992 | Dual Lumen | Withdrawn |
| 45436 | Needle Gauge 21 G | Withdrawn |
| 60M186111 | Dual Lumen | Withdrawn |
| 45472 | Needle Gauge 21 G | Withdrawn |
| 45457 | Catheter Gauge 4 Fr | Withdrawn |
| 45594 | Needle Gauge 21 G | Withdrawn |
| 45473 | Catheter Gauge 5 Fr | Withdrawn |
| 60M030701 | Catheter Gauge 3 Fr | Withdrawn |
| 60M7801210 | Catheter Gauge 4 Fr | Withdrawn |
| 45461 | Outer Diameter 1.7 mm | Withdrawn |
| 60M195821 | Catheter Gauge 5 Fr | Withdrawn |
| 60M080693 | Dual Lumen | Withdrawn |
| 45477 | Outer Diameter 1.95 mm | Withdrawn |
| 45471 | Outer Diameter 1.7 mm | Withdrawn |
| 45464 | Catheter Gauge 5 Fr | Withdrawn |
| 45435 | Catheter Gauge 3 Fr | Withdrawn |
| 60M080042 | Catheter Gauge 4 Fr | Withdrawn |
| 45462 | Needle Gauge 21 G | Withdrawn |
| 45437 | Length 60 cm | Withdrawn |
| 60M080041 | Catheter Gauge 5 Fr | Withdrawn |
| 60M701991 | Single Lumen | Withdrawn |
| 45474 | Catheter Gauge 5 Fr | Withdrawn |
| 60M030702 | Single Lumen | Withdrawn |
| 60M700052 | Catheter Gauge 5 Fr | Withdrawn |
| 45470 | Catheter Gauge 5 Fr | Withdrawn |
| 60M195331 | Catheter Gauge 5 Fr | Withdrawn |
| 60M250121 | Catheter Gauge 5 Fr | Withdrawn |
| 60M016962 | Single Lumen | Withdrawn |
| 60M080694 | Single Lumen | Withdrawn |
| 45459 | Outer Diameter 1.35 mm | Withdrawn |
| 45478 | Length 60 cm | Withdrawn |
| 60M150631 | Length 55 cm | Withdrawn |
| 45455 | Length 60 cm | Withdrawn |
| 60M780129 | Catheter Gauge 5 Fr | Withdrawn |
| 45479 | Catheter Gauge 6 Fr | Withdrawn |
| 60M195851 | Catheter Gauge 5 Fr | Withdrawn |
| 60M150632 | Catheter Gauge 5 Fr | Withdrawn |
| 45458 | Length 60 cm | Withdrawn |
| 60M700051 | Single Lumen | Withdrawn |
| 45598 | Length 60 cm | Withdrawn |
| 45591 | Needle Gauge 17 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163452 | 2017-02-03 |
| K152409 | 2015-09-24 |
| K150527 | 2015-03-31 |
| K150448 | 2015-03-19 |
| K142616 | 2014-10-14 |
| K140266 | 2014-03-05 |
| K133264 | 2013-11-20 |
| K131942 | 2013-07-31 |
| K131038 | 2013-05-09 |
| K122882 | 2012-10-18 |
| K121089 | 2012-08-23 |
| K121990 | 2012-08-03 |
| K111906 | 2011-07-29 |
| K101326 | 2010-09-02 |
| K093366 | 2009-11-24 |
| K091261 | 2009-05-12 |
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.