FDA 510(k)

MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)

K-Number: K040694 · 2004-03-25

Decision Date2004-03-25

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc.. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K040694. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)?

MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K040694.

When did MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) receive FDA 510(k) clearance?

MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040694.

Who is the listed applicant for MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)?

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

What is the FDA product code for MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)?

The FDA product code for MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) is HCG.

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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.