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FDA 510(k)

6F MACH 1, MODEL 34356-XXX

K-Number: K010874 · 2001-06-21

ApplicantBoston Scientific Corp
Decision Date2001-06-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

6F MACH 1, MODEL 34356-XXX 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 2001-06-21 under 510(k) number K010874. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 6F MACH 1, MODEL 34356-XXX?

6F MACH 1, MODEL 34356-XXX is a medical device that received FDA 510(k) clearance on 2001-06-21. The listed applicant is Boston Scientific Corp. The 510(k) number is K010874.

When did 6F MACH 1, MODEL 34356-XXX receive FDA 510(k) clearance?

6F MACH 1, MODEL 34356-XXX received FDA 510(k) clearance on 2001-06-21, under 510(k) number K010874.

Who is the listed applicant for 6F MACH 1, MODEL 34356-XXX?

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 6F MACH 1, MODEL 34356-XXX?

The FDA product code for 6F MACH 1, MODEL 34356-XXX is DQY.

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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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