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FDA 510(k)

40 CC GRANDE

K-Number: K974247 · 1998-02-10

ApplicantBoston Scientific Corp
Decision Date1998-02-10
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

40 CC GRANDE 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 1998-02-10 under 510(k) number K974247. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 40 CC GRANDE?

40 CC GRANDE is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Boston Scientific Corp. The 510(k) number is K974247.

When did 40 CC GRANDE receive FDA 510(k) clearance?

40 CC GRANDE received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974247.

Who is the listed applicant for 40 CC GRANDE?

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 40 CC GRANDE?

The FDA product code for 40 CC GRANDE is DSP.

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Related Devices (Code: DSP)

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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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