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)

MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT

K-Number: K862335 · 1986-07-24

ApplicantU.S. Mfg. & Management, Inc.
Decision Date1986-07-24
Product Code
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Mfg. & Management, Inc.. It received FDA 510(k) clearance on 1986-07-24 under 510(k) number K862335. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT?

MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT is a medical device that received FDA 510(k) clearance on 1986-07-24. The listed applicant is U.S. Mfg. & Management, Inc.. The 510(k) number is K862335.

When did MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT receive FDA 510(k) clearance?

MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT received FDA 510(k) clearance on 1986-07-24, under 510(k) number K862335.

Who is the listed applicant for MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT?

The FDA 510(k) record lists U.S. Mfg. & Management, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 U.S. Mfg. & Management, 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.

K920860CONTROLLED PASSIVE MOTION MACHINEK874436FLUID SAMPLING PACKK853242I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KIK842999VENI-SHIELD

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.

↑