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FDA 510(k)

PCW PERCUTANEOUS COMPRESSION WIRE

K-Number: K031050 · 2003-07-14

ApplicantMillennium Medical Technologies, Inc.
Decision Date2003-07-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PCW PERCUTANEOUS COMPRESSION WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Medical Technologies, Inc.. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K031050. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCW PERCUTANEOUS COMPRESSION WIRE?

PCW PERCUTANEOUS COMPRESSION WIRE is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is Millennium Medical Technologies, Inc.. The 510(k) number is K031050.

When did PCW PERCUTANEOUS COMPRESSION WIRE receive FDA 510(k) clearance?

PCW PERCUTANEOUS COMPRESSION WIRE received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031050.

Who is the listed applicant for PCW PERCUTANEOUS COMPRESSION WIRE?

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

What is the FDA product code for PCW PERCUTANEOUS COMPRESSION WIRE?

The FDA product code for PCW PERCUTANEOUS COMPRESSION WIRE is HWC. This falls under the Cardiovascular category.

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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.

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