FDA 510(k)

MODEL 9408 A TELETRACE

K-Number: K812703 · 1981-10-23

Decision Date1981-10-23

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 9408 A TELETRACE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K812703. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 9408 A TELETRACE?

MODEL 9408 A TELETRACE is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Medtronic Vascular. The 510(k) number is K812703.

When did MODEL 9408 A TELETRACE receive FDA 510(k) clearance?

MODEL 9408 A TELETRACE received FDA 510(k) clearance on 1981-10-23, under 510(k) number K812703.

Who is the listed applicant for MODEL 9408 A TELETRACE?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 9408 A TELETRACE?

The FDA product code for MODEL 9408 A TELETRACE is DXH. This falls under the Hematology category.

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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.