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)

IV START KITS

K-Number: K943047 · 1994-09-14

ApplicantSterile Concepts, Inc.
Decision Date1994-09-14
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV START KITS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1994-09-14 under 510(k) number K943047. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IV START KITS?

IV START KITS is a medical device that received FDA 510(k) clearance on 1994-09-14. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K943047.

When did IV START KITS receive FDA 510(k) clearance?

IV START KITS received FDA 510(k) clearance on 1994-09-14, under 510(k) number K943047.

Who is the listed applicant for IV START KITS?

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

What is the FDA product code for IV START KITS?

The FDA product code for IV START KITS is KMK.

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 Sterile Concepts, 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.

K951231ORTHOPEDIC PACKSK951081OB/GYN PACKSK952539RADIOLOGY PACKSK951478GENERAL AND PLASTIC SURGERY PACKSK944139DENTAL HYGIENE TRAYK943090SUTURE REMOVAL TRAYS

View all 10 devices →

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K941850IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILETnt Moborg Intl. , Ltd.

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.

↑