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)

JAIN BLOOD SHIELD

K-Number: K913896 · 1992-03-06

ApplicantJain Surgical Equipment, Inc.
Decision Date1992-03-06
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JAIN BLOOD SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Jain Surgical Equipment, Inc.. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K913896. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAIN BLOOD SHIELD?

JAIN BLOOD SHIELD is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is Jain Surgical Equipment, Inc.. The 510(k) number is K913896.

When did JAIN BLOOD SHIELD receive FDA 510(k) clearance?

JAIN BLOOD SHIELD received FDA 510(k) clearance on 1992-03-06, under 510(k) number K913896.

Who is the listed applicant for JAIN BLOOD SHIELD?

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

What is the FDA product code for JAIN BLOOD SHIELD?

The FDA product code for JAIN BLOOD SHIELD is JOL.

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 Jain Surgical Equipment, 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.

K911077JAIN SUTURE PACKAGE COUNTERK911076JAIN QUICK COUNTK905105JAIN SUTURE/VESIBAND ORGANIZERK904536JAIN GRAFT ASSIST

Related Devices (Code: JOL)

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.

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare CorpK000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories

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.

↑