FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX— 510(k) K970700
Substantially EquivalentFresenius USA, Inc.
FDA 510(k) clearance K970700 for FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX, Substantially Equivalent on 1998-09-15. Applicant: Fresenius USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Fresenius USA, Inc.
- Product code
- Code MSE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Creek, CA, US
Recent devices under product code MSE
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- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
- K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
More clearances from Fresenius USA, Inc.
view all- K992275 — FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
- K974584 — FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
- K973378 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61
- K961465 — 2008H ON LINE CLEARANCE MONITOR
- K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.