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FDA 510(k)

ACUTRAK PLUS FIXATION SYSTEM

K-Number: K944330 · 1995-05-05

ApplicantAcu Med, Inc.
Decision Date1995-05-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACUTRAK PLUS FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K944330. 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 for Some Indications.

Frequently Asked Questions

What is the ACUTRAK PLUS FIXATION SYSTEM?

ACUTRAK PLUS FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Acu Med, Inc.. The 510(k) number is K944330.

When did ACUTRAK PLUS FIXATION SYSTEM receive FDA 510(k) clearance?

ACUTRAK PLUS FIXATION SYSTEM received FDA 510(k) clearance on 1995-05-05, under 510(k) number K944330.

Who is the listed applicant for ACUTRAK PLUS FIXATION SYSTEM?

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

What is the FDA product code for ACUTRAK PLUS FIXATION SYSTEM?

The FDA product code for ACUTRAK PLUS FIXATION SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Acu Med, Inc. as applicant

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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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