FDA 510(k)

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT

K-Number: K032497 · 2003-09-25

Decision Date2003-09-25

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT 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 2003-09-25 under 510(k) number K032497. 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 SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT?

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Micro Therapeutics, Inc.. The 510(k) number is K032497.

When did SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT receive FDA 510(k) clearance?

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT received FDA 510(k) clearance on 2003-09-25, under 510(k) number K032497.

Who is the listed applicant for SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT?

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 SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT?

The FDA product code for SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT is HCG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.