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)

COLLAR BUTTON VENTURI VENT TUBE

K-Number: K943848 · 1994-09-16

ApplicantMicromed Development Corp.
Decision Date1994-09-16
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

COLLAR BUTTON VENTURI VENT TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Micromed Development Corp.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K943848. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAR BUTTON VENTURI VENT TUBE?

COLLAR BUTTON VENTURI VENT TUBE is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Micromed Development Corp.. The 510(k) number is K943848.

When did COLLAR BUTTON VENTURI VENT TUBE receive FDA 510(k) clearance?

COLLAR BUTTON VENTURI VENT TUBE received FDA 510(k) clearance on 1994-09-16, under 510(k) number K943848.

Who is the listed applicant for COLLAR BUTTON VENTURI VENT TUBE?

The FDA 510(k) record lists Micromed Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLAR BUTTON VENTURI VENT TUBE?

The FDA product code for COLLAR BUTTON VENTURI VENT TUBE is ETD.

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 Micromed Development Corp. 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.

K945105POLY/PLATINUM WIRE PISTONK945831DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KITK945242NERVE MONITOR ELECTRODES/STIMULATOR PROBESK945107POLY-WIRE PISTONK945104MICROMED PARTIAL REGULAR AND PARTIAL OFFSETK945106MICROMED TOTAL REGULAR AND PARTIAL OFFSET

View all 14 devices →

Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, 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.

↑