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)

PIV SYSTEM

K-Number: K981032 · 1998-09-02

ApplicantMedical Solutions, Inc.
Decision Date1998-09-02
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PIV SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Solutions, Inc.. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K981032. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIV SYSTEM?

PIV SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Medical Solutions, Inc.. The 510(k) number is K981032.

When did PIV SYSTEM receive FDA 510(k) clearance?

PIV SYSTEM received FDA 510(k) clearance on 1998-09-02, under 510(k) number K981032.

Who is the listed applicant for PIV SYSTEM?

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

What is the FDA product code for PIV SYSTEM?

The FDA product code for PIV SYSTEM is LDQ.

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 Medical Solutions, 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.

K0418398NONEK012276TEMP 3K980086HEAT STACK

Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.K945374ACU-HALTEva-Health USA, 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.

↑