FDA 510(k)

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER

K-Number: K952343 · 1995-12-22

ApplicantNational Medical Care, Medical Products Div., Inc.

Decision Date1995-12-22

Product CodeFJI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K952343. 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 FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER?

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K952343.

When did FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1995-12-22, under 510(k) number K952343.

Who is the listed applicant for FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER?

The FDA product code for FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER 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 National Medical Care, Medical Products Div., Inc. as applicant

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SET K941757FORMALIN REUSE CART K930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R K920586DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET K920029DEXTROLYTE II CAPD TRNSFER SET

View all 62 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.