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)

NAVARRE PERCUTANEOUS ACCESS SET

K-Number: K942315 · 1994-07-08

ApplicantNavarre Biomedical , Ltd.
Decision Date1994-07-08
Product CodeKGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NAVARRE PERCUTANEOUS ACCESS SET is the device name listed in this FDA 510(k) record. The listed applicant is Navarre Biomedical , Ltd.. It received FDA 510(k) clearance on 1994-07-08 under 510(k) number K942315. The device is classified under product code KGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVARRE PERCUTANEOUS ACCESS SET?

NAVARRE PERCUTANEOUS ACCESS SET is a medical device that received FDA 510(k) clearance on 1994-07-08. The listed applicant is Navarre Biomedical , Ltd.. The 510(k) number is K942315.

When did NAVARRE PERCUTANEOUS ACCESS SET receive FDA 510(k) clearance?

NAVARRE PERCUTANEOUS ACCESS SET received FDA 510(k) clearance on 1994-07-08, under 510(k) number K942315.

Who is the listed applicant for NAVARRE PERCUTANEOUS ACCESS SET?

The FDA 510(k) record lists Navarre Biomedical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVARRE PERCUTANEOUS ACCESS SET?

The FDA product code for NAVARRE PERCUTANEOUS ACCESS SET is KGZ.

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 Navarre Biomedical , Ltd. 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.

K955110NAVARRE PERCUTANEOUS BILIARY DRAINAGEK955505OPTI-DRAIN MULTI-USE DRAINAGE CATHETERK945909NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETERK951907NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETERK951475NAVARRE UNIVERSAL DRAINAGE CATHETERK943663NAVARRE 600 ML DRAINAGE BAG

View all 9 devices →

Related Devices (Code: KGZ)

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.

K022306AART SILICONE TUBINGAesthetic and Reconstructive Technologies, Inc.K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron MedicalK973183WOUND DRAINAGE HOLDERR & D Medical Products, Inc.K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.K896087PALESTRANT IRRIGATION AND DRAINAGE SETNorth American Instrument Corp.K895041OPTICAL CATHETER(TM) INTRODUCER SETSMedical Dynamics, 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.

↑