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)

LUER LOCK ADAPTER/NUT

K-Number: K862653 · 1986-07-31

ApplicantMallinckrodt Critical Care
Decision Date1986-07-31
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUER LOCK ADAPTER/NUT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1986-07-31 under 510(k) number K862653. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUER LOCK ADAPTER/NUT?

LUER LOCK ADAPTER/NUT is a medical device that received FDA 510(k) clearance on 1986-07-31. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K862653.

When did LUER LOCK ADAPTER/NUT receive FDA 510(k) clearance?

LUER LOCK ADAPTER/NUT received FDA 510(k) clearance on 1986-07-31, under 510(k) number K862653.

Who is the listed applicant for LUER LOCK ADAPTER/NUT?

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

What is the FDA product code for LUER LOCK ADAPTER/NUT?

The FDA product code for LUER LOCK ADAPTER/NUT is FPA.

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 Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

View all 92 devices →

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑