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FDA 510(k)

CONSTELLATION CATHETER, MODEL 8031

K-Number: K003782 · 2001-02-14

ApplicantBoston Scientific Corp
Decision Date2001-02-14
Product CodeMTD
Advisory CommitteeCV
DecisionUnknown

Device Summary

CONSTELLATION CATHETER, MODEL 8031 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 2001-02-14 under 510(k) number K003782. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CONSTELLATION CATHETER, MODEL 8031?

CONSTELLATION CATHETER, MODEL 8031 is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Boston Scientific Corp. The 510(k) number is K003782.

When did CONSTELLATION CATHETER, MODEL 8031 receive FDA 510(k) clearance?

CONSTELLATION CATHETER, MODEL 8031 received FDA 510(k) clearance on 2001-02-14, under 510(k) number K003782.

Who is the listed applicant for CONSTELLATION CATHETER, MODEL 8031?

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 CONSTELLATION CATHETER, MODEL 8031?

The FDA product code for CONSTELLATION CATHETER, MODEL 8031 is MTD.

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Related Devices (Code: MTD)

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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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