510(k) K143102
- Device
- Multi-Lumen Acute Hemodialysis Catheter For High Volume Infusions
- Applicant
- Arrow International, Inc. (Subsidiary Of Teleflex Inc.)
- 510(k) number
- K143102
- Product code
- NIE
- Decision
- Substantially Equivalent - Kit With Drugs (SEKD)
- Decision date
- 2015-07-24
- Date received
- 2014-10-29
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Triple Lumen, Non-implanted
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Debra Grodt
- Address
- 2400 Bernville Rd. Reading PA US 19605 19605
FDA Registration Numbers#
- 1721676
- 3009211636
- 3007544634
- 1018233
- 9680794
- 2011171
- 3006260740
- 3010882065
- 1000563940
- 9610849
- 1319639
- 1282497
- 3030574705
- 9617592
- 3015859709
- 3006082230
- 2030624
- 3003915875
- 3009888344
- 2518902
Source Documents#
Other 510(k) Records For Product Code NIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. (dba MedComp) | 2023-11-16 |
| K222170 | Power Acute Triple Lumen Hemodialysis Catheter | Health Line International Corporation | 2023-01-13 |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2019-06-14 |
| K181175 | 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (dba MedComp) | 2018-07-05 |
| K141531 | POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2015-06-01 |
| K133456 | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER | C.R. Bard, Inc. | 2014-09-24 |
| K123292 | T3 | Medcomp | 2013-06-11 |
| K102605 | MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010-12-22 |
| K083675 | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER | C.R. Bard, Inc. | 2009-03-19 |
| K033570 | MEDCOMP T-3 | Medcomp | 2004-09-16 |
| K020089 | MAHURKAR TRIPLE LUMEN CATHETER, 12 FR | The Kendall Company | 2002-04-10 |
Legacy Summary#
summary
FDA Review#
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