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)

SAFELINE I.V. BAG ACCESS DEVICE

K-Number: K955594 · 1996-03-06

ApplicantMcgaw, Inc.
Decision Date1996-03-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFELINE I.V. BAG ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mcgaw, Inc.. It received FDA 510(k) clearance on 1996-03-06 under 510(k) number K955594. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFELINE I.V. BAG ACCESS DEVICE?

SAFELINE I.V. BAG ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is Mcgaw, Inc.. The 510(k) number is K955594.

When did SAFELINE I.V. BAG ACCESS DEVICE receive FDA 510(k) clearance?

SAFELINE I.V. BAG ACCESS DEVICE received FDA 510(k) clearance on 1996-03-06, under 510(k) number K955594.

Who is the listed applicant for SAFELINE I.V. BAG ACCESS DEVICE?

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 SAFELINE I.V. BAG ACCESS DEVICE?

The FDA product code for SAFELINE I.V. BAG ACCESS DEVICE is LHI.

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 SETSK955595SAFELINE MULTIDOSE VIAL ADAPTERK941244SAFELINE SYSTEM TURN LOCK CANNULAK932165INTRAVASCULAR ADMINISTRATION SETK931377SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENTK932856IRRIGATION ACCESS CAP

View all 13 devices →

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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.

↑