510(k) K102043
- Device
- ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
- Applicant
- REX MEDICAL
- 510(k) number
- K102043
- Product code
- MSD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-18
- Date received
- 2010-07-20
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Implanted
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN- FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 1722746
- 3012050423
- 3004134316
- 2183744
- 3008998256
- 3014461810
- 2527072
- 3017210488
- 9611665
- 3007544634
- 2528981
- 3008110587
- 3016727301
- 3015309643
- 3006950086
- 3011642792
- 2030598
- 3033589330
- 3009211636
- 3002807314
- 3010882065
- 3030574705
- 3013750125
- 2518902
- 2020394
- 1625425
- 3011534620
- 3006942602
- 3004111573
- 1721676
- 3005987240
- 9680794
- 9617592
- 1721504
- 1644312
- 1724474
- 3015453963
- 3035111606
- 9610849
- 3006260740
- 2030624
- 1833566
- 3015225571
- 3006082230
- 3011137372
- 1319639
- 1018233
- 3015859709
- 3012536737
- 3013557562
- 3007137787
- 1061124
- 1282497
- 3010041511
- 3003915875
Source Documents#
Other 510(k) Records For Product Code MSD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | 2025-05-16 |
| K210461 | End Cap | Medical Components Inc (Medcomp) | 2021-09-14 |
| K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | C.R. Bard, Inc. | 2021-07-01 |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Bard Peripheral Vascular, Inc. | 2021-06-04 |
| K203767 | Pristine Long-Term Hemodialysis Catheter | C B Bard, Inc. | 2021-04-02 |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020-11-18 |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | Medical Components, Inc. (dba MedComp) | 2020-09-03 |
| K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | 2020-06-22 |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters | C. R. Bard | 2020-03-05 |
| K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies , Ltd. | 2019-05-31 |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes | Medical Components, Inc. (dba MedComp) | 2018-05-17 |
| K173805 | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) | Marvao Medical Devices, Ltd. | 2018-02-08 |
| K171571 | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | Marvao Medical Devices, Ltd. | 2017-11-30 |
| K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017-11-16 |
| K161026 | NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) | Marvao Medical Devices, Ltd. | 2016-08-09 |
Legacy Summary#
summary
FDA Review#
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