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)

MODIFICATION TO IV SPIKE

K-Number: K921860 · 1992-07-30

ApplicantMcgaw, Inc.
Decision Date1992-07-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO IV SPIKE is the device name listed in this FDA 510(k) record. The listed applicant is Mcgaw, Inc.. It received FDA 510(k) clearance on 1992-07-30 under 510(k) number K921860. 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 MODIFICATION TO IV SPIKE?

MODIFICATION TO IV SPIKE is a medical device that received FDA 510(k) clearance on 1992-07-30. The listed applicant is Mcgaw, Inc.. The 510(k) number is K921860.

When did MODIFICATION TO IV SPIKE receive FDA 510(k) clearance?

MODIFICATION TO IV SPIKE received FDA 510(k) clearance on 1992-07-30, under 510(k) number K921860.

Who is the listed applicant for MODIFICATION TO IV SPIKE?

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

What is the FDA product code for MODIFICATION TO IV SPIKE?

The FDA product code for MODIFICATION TO IV SPIKE 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 Mcgaw, 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.

K972678MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETSK955594SAFELINE I.V. BAG ACCESS DEVICEK955595SAFELINE MULTIDOSE VIAL ADAPTERK941244SAFELINE SYSTEM TURN LOCK CANNULAK932165INTRAVASCULAR ADMINISTRATION SETK931377SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT

View all 13 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.

↑