FDA Product Code
FDA Product Code KOC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 182 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K831338 | LUNDIA 10-3-L PARALLEL FLOW DIALYZER | Gambro, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K830905 | LUNDIA 10-2-N PARALLEL FLOW DIALYZER | Gambro, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K823839 | AMPCO KIDNEY DIALYSIS TRAY | Associated Medical Products Co. | 1983-03-29 | Traditional | PDF ↗ |
| K830291 | WAK WEARABLE ARTIFICIAL KIDNEY | Wak-Utah | 1983-03-29 | Traditional | PDF ↗ |
| K830729 | C-DAK ARTIFICIAL KIDNEY | Cordis Corp. | 1983-03-29 | Traditional | PDF ↗ |
| K830183 | ASAHI HOLLOW FIBER KIDNEYS NR SERIES | Advocacy International, Ltd. | 1983-03-17 | Traditional | PDF ↗ |
| K830231 | ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES | Advocacy International, Ltd. | 1983-03-17 | Traditional | PDF ↗ |
| K822339 | KF-101-13 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | Traditional | PDF ↗ |
| K822337 | KF-101-07 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | Traditional | PDF ↗ |
| K822338 | KF-101-10 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | Traditional | PDF ↗ |
| K823715 | SINGLE ACCESS DEVICE (SSAD) | Samaritan Hospital | 1983-02-07 | Traditional | PDF ↗ |
| K823068 | MEDISYSTEMS FISTULA NEEDLES | Medisystems Corp. | 1983-01-26 | Traditional | PDF ↗ |
| K823069 | KF-E SERIES HOLLOW FIBER DIALYZER | Medisystems Corp. | 1983-01-21 | Traditional | PDF ↗ |
| K823733 | EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR | Advocacy International, Ltd. | 1983-01-14 | Traditional | PDF ↗ |
| K830021 | A.V. FISTULA CANNULATION SETS | Travenol Laboratories, S.A. | 1983-01-14 | Traditional | PDF ↗ |
| K823791 | LUNDIA 10-5-L PARRALLE FLOW DIALYZER | Gambro, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K823826 | CAPILLARY FLOW DIALYZERS | Travenol Laboratories, S.A. | 1983-01-12 | Traditional | PDF ↗ |
| K823778 | GAMMA STERILIZED CAPILLARY FLOW DIALYZ | Travenol Laboratories, S.A. | 1983-01-07 | Traditional | PDF ↗ |
| K823707 | HOSPAL BLOOD LINES | Hospal Medical Corp. | 1983-01-05 | Traditional | PDF ↗ |
| K823546 | RENAFLO II | Renal Systems, Inc. | 1982-12-16 | Traditional | PDF ↗ |
| K823375 | NEPHROSS, ANDANTE H.F. | Organon Teknika Corp. | 1982-12-07 | Traditional | PDF ↗ |
| K822340 | EXTRACORPOREAL SINGLE NEEDLE MODULE | Extracorporeal Medical Specialities, Inc. | 1982-11-03 | Traditional | PDF ↗ |
| K822796 | NEGATIVE PRESSURE ARTERIAL BLOOD LINE | Erika, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K822738 | TRIEX-IH DIALYZER | Extracorporeal Medical Specialities, Inc. | 1982-09-24 | Traditional | PDF ↗ |
| K822244 | NEPHROSOL | Dialysis Systems, Inc. | 1982-09-02 | Traditional | PDF ↗ |
| K822283 | TS-000 ARTERIOVENOUS BLOOD TUBING SET | Extracorporeal Medical Specialities, Inc. | 1982-08-27 | Traditional | PDF ↗ |
| K822225 | ERIKA NEGAT. PRESSURE ARTER. BLOOD LINE | Erika, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K822049 | LUNDIA 10-5 N PARALLEL FLOW DIALYZER | Gambro, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K822226 | ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN | Erika, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K821367 | GF-180-M & GF-180-H HEMODIALYZERS | Gambro, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K821495 | DISPOSABLE BLOOD LINE CONNECTORS | Bentley Laboratories, Inc. | 1982-05-27 | Traditional | PDF ↗ |
| K812498 | CLIRANS TE12 HOLLOW FIBER DIALYZER | Terumo Medical Corp. | 1981-09-29 | Traditional | PDF ↗ |
| K811981 | ISOLATER THP | Tri-Med, Inc. | 1981-08-04 | Traditional | PDF ↗ |
| K811977 | HEMASITE ACCESS MONITOR (TENT.) #RS-8200 | Renal Systems, Inc. | 1981-07-31 | Traditional | PDF ↗ |
| K811457 | MODEL RS-8100 | Rinal Systems, Inc. | 1981-06-23 | Traditional | PDF ↗ |
| K810480 | SCANLAN SUTURE BOOTS | Scanlan Intl., Inc. | 1981-03-13 | Traditional | PDF ↗ |
| K810074 | ACCUFLO 100 | Renal Care Corp. | 1981-03-04 | Traditional | PDF ↗ |
| K801356 | BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET | Cordis Corp. | 1980-07-08 | Traditional | PDF ↗ |
| K801355 | BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR | Cordis Corp. | 1980-07-08 | Traditional | PDF ↗ |
| K801354 | BIONICS ARTERIAL/VENOUS FISTULA NEEDLE | Cordis Corp. | 1980-07-08 | Traditional | PDF ↗ |
| K792277 | MODEL 7620 LINE CLAMP | B-D Drake Willock | 1980-01-16 | Traditional | PDF ↗ |
| K791411 | COAXIAL DUAL FLOW CATHETER | Terumo America, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K790841 | TG 2, TRI-GARD PRESSURE MONITOR | Sorensen Research | 1979-06-27 | Traditional | PDF ↗ |
| K790591 | HEMODIALYSIS BLOOD CIRCUIT | Travenol Laboratories, S.A. | 1979-05-02 | Traditional | PDF ↗ |
| K790381 | ARTERIOVENOUS SETS | Extracorporeal Medical Specialities, Inc. | 1979-04-20 | Traditional | PDF ↗ |
| K781050 | DLC 500, DOUBLE LUMEN CATHETER | Hemodialysis, Division of The | 1978-09-26 | Traditional | PDF ↗ |
| K771424 | TUBE OCCLUDING FORCEPS | Quinton, Inc. | 1977-08-26 | Traditional | PDF ↗ |
| K770691 | GAMBRO VENOUS BLOOD LINE | Gambro, Inc. | 1977-04-28 | Traditional | PDF ↗ |
| K770482 | CATHETER, SINGLE PUNCTURE Y | Mdl Medical Device Laboratories, Inc. | 1977-04-15 | Traditional | PDF ↗ |
| K770552 | CATHETER, KIDNEY DIALYSIS, HEMO-CATH II | Medical Disposables Intl., Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K770524 | TRANSDUCER PROTECTOR, RT-901, RT-902 | Renal Systems, Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K770475 | PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 | Travenol Laboratories, S.A. | 1977-03-16 | Traditional | PDF ↗ |
| K770382 | NEEDLE, FISTULA, ERIKA | Erika, Inc. | 1977-03-08 | Traditional | PDF ↗ |
| K770383 | STOPCOCK, ONE WAY | Cobe Laboratories, Inc. | 1977-03-07 | Traditional | PDF ↗ |
| K770213 | BARIOR | Tri-Med, Inc. | 1977-02-07 | Traditional | PDF ↗ |
| K770048 | DNC 162 VINCA-FLO | Sorensen Research | 1977-01-14 | Traditional | PDF ↗ |
| K770045 | DNC 152 VINCA-FLO | Sorensen Research | 1977-01-14 | Traditional | PDF ↗ |
| K770043 | DNC 161 VINCA-FLO | Sorensen Research | 1977-01-14 | Traditional | PDF ↗ |
| K770044 | DNC 141 VINCA-FLO | Sorensen Research | 1977-01-14 | Traditional | PDF ↗ |
| K770046 | DNC 142 VINCA-FLO | Sorensen Research | 1977-01-14 | Traditional | PDF ↗ |
| K760994 | MONITOR LINE W/FILTER & NEEDLE | Dravon Medical, Inc. | 1977-01-06 | Traditional | PDF ↗ |
| K761051 | BI-FLOW NEEDLE | Dws, Inc. | 1976-12-30 | Traditional | PDF ↗ |
| K761081 | SINGLE NEEDLE HEMODIALYSIS (BFC-161) | Sorensen Research | 1976-12-06 | Traditional | PDF ↗ |
| K761082 | SINGLE NEEDLE HEMODIALYSIS (BFC-142) | Sorensen Research | 1976-12-06 | Traditional | PDF ↗ |
| K761038 | SINGLE NEEDLE HEMODIALYSIS | Sorensen Research | 1976-12-06 | Traditional | PDF ↗ |
| K761078 | HEMO-CATH I, KIDNEY DIALYSIS CATHETER | Medical Disposables Intl., Inc. | 1976-12-06 | Traditional | PDF ↗ |
| K760935 | WINGED FISTULA NEEDLE | Gambro, Inc. | 1976-11-19 | Traditional | PDF ↗ |
| K760665 | FISTULA NEEDLE (#11-265) | Cobe Laboratories, Inc. | 1976-10-21 | Traditional | PDF ↗ |
| K760626 | FILTER SET PMF 2288 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760633 | FILTER SET PMF 1028 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760631 | FILTER SET 1288 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760625 | FILTER SET PMF 1168 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760637 | FILTER SET, PMF 1448 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760640 | FILTER SET, PMF 1024 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760628 | FILTER SET PMF 2448 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760629 | FILTER SET PMF 100 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760632 | FILTER SET PMF 2024 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760627 | FILTER SET PMF 2168 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760639 | FILTER SET, PMF 2028 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760638 | FILTER, PMF 1000 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760630 | FILTER SET PMF 200 | Sorensen Research | 1976-10-15 | Traditional | PDF ↗ |
| K760042 | BLOOD TUBING SETS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-30 | Traditional | PDF ↗ |
Product code KOC · Class II · Gastroenterology, Urology. Data: openFDA.