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FDA 510(k)

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

K-Number: K062852 · 2007-02-23

ApplicantOnset Medical Corporation
Decision Date2007-02-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 is the device name listed in this FDA 510(k) record. The listed applicant is Onset Medical Corporation. It received FDA 510(k) clearance on 2007-02-23 under 510(k) number K062852. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870?

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Onset Medical Corporation. The 510(k) number is K062852.

When did BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 receive FDA 510(k) clearance?

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 received FDA 510(k) clearance on 2007-02-23, under 510(k) number K062852.

Who is the listed applicant for BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870?

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

What is the FDA product code for BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870?

The FDA product code for BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 is DYB.

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Related Devices (Code: DYB)

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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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