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FDA 510(k)

BALT INTRODUCER

K-Number: K925633 · 1993-06-25

ApplicantTarget Therapeutics
Decision Date1993-06-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BALT INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1993-06-25 under 510(k) number K925633. 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 BALT INTRODUCER?

BALT INTRODUCER is a medical device that received FDA 510(k) clearance on 1993-06-25. The listed applicant is Target Therapeutics. The 510(k) number is K925633.

When did BALT INTRODUCER receive FDA 510(k) clearance?

BALT INTRODUCER received FDA 510(k) clearance on 1993-06-25, under 510(k) number K925633.

Who is the listed applicant for BALT INTRODUCER?

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

What is the FDA product code for BALT INTRODUCER?

The FDA product code for BALT INTRODUCER is DYB.

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Related Devices (Code: DYB)

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.

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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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