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FDA 510(k)

MEDNOVA SAFETY BAG

K-Number: K853075 · 1985-10-16

ApplicantMednova Corp.
Decision Date1985-10-16
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDNOVA SAFETY BAG is the device name listed in this FDA 510(k) record. The listed applicant is Mednova Corp.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853075. 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 MEDNOVA SAFETY BAG?

MEDNOVA SAFETY BAG is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Mednova Corp.. The 510(k) number is K853075.

When did MEDNOVA SAFETY BAG receive FDA 510(k) clearance?

MEDNOVA SAFETY BAG received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853075.

Who is the listed applicant for MEDNOVA SAFETY BAG?

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

What is the FDA product code for MEDNOVA SAFETY BAG?

The FDA product code for MEDNOVA SAFETY BAG 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 Mednova Corp. 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.

K854813MEDNOVA BLOOD PRESSURE CUFF

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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