510(k) K832623
- Device
- TOP DISPOS. INFUSION SET/HEMODIALY
- Applicant
- TOP SURGICAL MANUFACTURERS CO.
- 510(k) number
- K832623
- Product code
- KOC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-08-04
- Regulation
- 876.5820
- Classification name
- Accessories, Blood Circuit, Hemodialysis
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3000247873
- 1018470
- 1720929
- 3005162618
- 3017636737
- 3004202080
- 9611823
- 2029275
- 3003464075
- 8041145
- 3018348
- 3033903155
- 3035708507
- 3014638255
- 3043014136
- 3006755813
- 3038195011
- 1424263
- 3030446844
- 1625519
- 3023981687
- 1625425
- 3008252904
- 3004111573
- 3005987240
- 3016096143
- 1644312
- 3006849754
- 9616074
- 8030665
- 1932668
- 3010202439
- 2032112
- 1643817
- 1649518
- 9617473
- 2020550
- 3015335038
- 3014936217
- 9680579
- 3027859369
- 3012494290
- 3005578748
- 3013557562
- 1225714
- 3043226252
- 9611824
- 1650907
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KOC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. | 2025-05-15 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. | 2025-05-15 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | 2023-07-28 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | NIKKISO CO., LTD. | 2023-06-16 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| K172238 | CAREline Airless Hemodialysis Blood Tubing Sets | Fresenius Medical Care Renal Therapies Group, LLC | 2017-12-14 |
| K160749 | CRIT-LINE III Blood Chamber II | Fresenius Medical Care Renal Therapies Group, LLC | 2016-04-15 |
| K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care North America | 2015-11-05 |
| K141997 | CRIT-LINE IV SYSTEM | Fresenius Medical Care | 2015-04-01 |
| K141281 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-08-14 |
| K121599 | CRIT-LINE CLIP (CLIC) | Fresenius Medical Care-North America | 2012-11-09 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P | NIKKISO CO., LTD. | 2009-03-30 |
| K081740 | HEMOBAND, MODELS HB-NS AND HB-NSXL | Innovations For Access, Inc. | 2009-03-12 |
| K082758 | PRISMAFLO II | Stihler Electronic GmbH | 2008-12-19 |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | Nxstage Medical, Inc. | 2008-07-07 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases