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)

NIKKISO INFUSION PUMP MODEL PFA-02

K-Number: K861539 · 1986-07-31

ApplicantInternational Medical Products, Inc.
Decision Date1986-07-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIKKISO INFUSION PUMP MODEL PFA-02 is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Products, Inc.. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K861539. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIKKISO INFUSION PUMP MODEL PFA-02?

NIKKISO INFUSION PUMP MODEL PFA-02 is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is International Medical Products, Inc.. The 510(k) number is K861539.

When did NIKKISO INFUSION PUMP MODEL PFA-02 receive FDA 510(k) clearance?

NIKKISO INFUSION PUMP MODEL PFA-02 received FDA 510(k) clearance on 1986-07-31, under 510(k) number K861539.

Who is the listed applicant for NIKKISO INFUSION PUMP MODEL PFA-02?

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

What is the FDA product code for NIKKISO INFUSION PUMP MODEL PFA-02?

The FDA product code for NIKKISO INFUSION PUMP MODEL PFA-02 is FRN.

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 International Medical Products, Inc. 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.

K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESK973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATEK971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSISK920077NIKKISO NK PUMPK923942RHOMBO MEDICAL RHOMBO-FILLK900755DIGITAL CUFF PV GAUGE

View all 9 devices →

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

↑