Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS

K-Number: K950602 · 1995-11-30

ApplicantReprocessing Products Corp
Decision Date1995-11-30
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Reprocessing Products Corp. It received FDA 510(k) clearance on 1995-11-30 under 510(k) number K950602. 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 PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS?

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS is a medical device that received FDA 510(k) clearance on 1995-11-30. The listed applicant is Reprocessing Products Corp. The 510(k) number is K950602.

When did PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS receive FDA 510(k) clearance?

PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS received FDA 510(k) clearance on 1995-11-30, under 510(k) number K950602.

Who is the listed applicant for PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS?

The FDA 510(k) record lists Reprocessing Products Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS?

The FDA product code for PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED 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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Reprocessing Products Corp as applicant

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.

K123805E-Z CHEK BLOOD LEAK TEST STRIPSK101750RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104K090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEK974426POTENCY TEST STRIPS, INDICATOR TEST STRIPSK974064MICRO X RESIDUAL TEST STRIPS

Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE 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.

↑