HemoStar XK Long-Term Hemodialysis Catheter
HEMOSTAR XK Long-Term Hemodialysis Catheter 16F Standard Kit (Straight) (35cm)
2manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-06-17 |
| Record revised | 2026-03-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5 |
| Sizes | Catheter gauge 16 Fr; length 19 to 42 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5885270 | Catheter Gauge 16 Fr | In distribution |
| 5885150 | Length 19 cm | In distribution |
| 5883270 | Catheter Gauge 16 Fr | In distribution |
| 5883310 | Catheter Gauge 16 Fr | In distribution |
| 5885230 | Length 28 cm | In distribution |
| 5885190 | Length 24 cm | In distribution |
| 5883690 | Catheter Gauge 16 Fr | In distribution |
| 5884420 | Catheter Gauge 16 Fr | In distribution |
| 5883350 | Catheter Gauge 16 Fr | In distribution |
| 5883730 | Length 23 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 406 |
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053589 | 2006-04-13 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-08-07 | Class III | Incorrect or no expiration date | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013. | 120 units | 2013-01-07 |
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.