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FDA 510(k)

DBT, DYNAMIC BUBBLE TRAP

K-Number: K031323 · 2003-08-01

Decision Date2003-08-01
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DBT, DYNAMIC BUBBLE TRAP is the device name listed in this FDA 510(k) record. The listed applicant is Convergenza AG. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K031323. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBT, DYNAMIC BUBBLE TRAP?

DBT, DYNAMIC BUBBLE TRAP is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Convergenza AG. The 510(k) number is K031323.

When did DBT, DYNAMIC BUBBLE TRAP receive FDA 510(k) clearance?

DBT, DYNAMIC BUBBLE TRAP received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031323.

Who is the listed applicant for DBT, DYNAMIC BUBBLE TRAP?

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

What is the FDA product code for DBT, DYNAMIC BUBBLE TRAP?

The FDA product code for DBT, DYNAMIC BUBBLE TRAP is DTM.

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.

Related Devices (Code: DTM)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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