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)

HEPARIN MICRO-INFUSOR

K-Number: K853664 · 1986-03-18

ApplicantY
Decision Date1986-03-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEPARIN MICRO-INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1986-03-18 under 510(k) number K853664. 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 HEPARIN MICRO-INFUSOR?

HEPARIN MICRO-INFUSOR is a medical device that received FDA 510(k) clearance on 1986-03-18. The listed applicant is Y. The 510(k) number is K853664.

When did HEPARIN MICRO-INFUSOR receive FDA 510(k) clearance?

HEPARIN MICRO-INFUSOR received FDA 510(k) clearance on 1986-03-18, under 510(k) number K853664.

Who is the listed applicant for HEPARIN MICRO-INFUSOR?

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

What is the FDA product code for HEPARIN MICRO-INFUSOR?

The FDA product code for HEPARIN MICRO-INFUSOR 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 Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

View all 78 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.

↑