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FDA 510(k)

POLYETHYLENE VENT TUBES

K-Number: K943281 · 1994-08-24

ApplicantMicromed Development Corp.
Decision Date1994-08-24
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POLYETHYLENE VENT TUBES 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 1994-08-24 under 510(k) number K943281. 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 POLYETHYLENE VENT TUBES?

POLYETHYLENE VENT TUBES is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Micromed Development Corp.. The 510(k) number is K943281.

When did POLYETHYLENE VENT TUBES receive FDA 510(k) clearance?

POLYETHYLENE VENT TUBES received FDA 510(k) clearance on 1994-08-24, under 510(k) number K943281.

Who is the listed applicant for POLYETHYLENE VENT TUBES?

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 POLYETHYLENE VENT TUBES?

The FDA product code for POLYETHYLENE VENT TUBES is ETD.

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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

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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.

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