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FDA 510(k)

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028

K-Number: K980851 · 1998-04-22

ApplicantBoston Scientific Corp
Decision Date1998-04-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1998-04-22 under 510(k) number K980851. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028?

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 is a medical device that received FDA 510(k) clearance on 1998-04-22. The listed applicant is Boston Scientific Corp. The 510(k) number is K980851.

When did GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 receive FDA 510(k) clearance?

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 received FDA 510(k) clearance on 1998-04-22, under 510(k) number K980851.

Who is the listed applicant for GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028?

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

What is the FDA product code for GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028?

The FDA product code for GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 is IYO.

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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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