FDA 510(k)

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS

K-Number: K962309 · 1996-12-27

ApplicantAlthin Medical AB an Affiliate of Baxter Intl

Decision Date1996-12-27

Product CodeFJI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. It received FDA 510(k) clearance on 1996-12-27 under 510(k) number K962309. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS?

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS is a medical device that received FDA 510(k) clearance on 1996-12-27. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K962309.

When did ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS receive FDA 510(k) clearance?

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS received FDA 510(k) clearance on 1996-12-27, under 510(k) number K962309.

Who is the listed applicant for ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS?

The FDA 510(k) record lists Althin Medical AB an Affiliate of Baxter Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS?

The FDA product code for ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS is FJI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Althin Medical AB an Affiliate of Baxter Intl as applicant

K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 K970679ALTRA FLUX 200 HEMODIALYZER K970681ALTRA NOVA 200 HEMODIALYZER K970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM K964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM K955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

View all 27 devices →

Related Devices (Code: FJI)

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC K122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical Corporation K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products K010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.