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Auto-Vac Autotransfusion Reserv, Model 7900

FDA 510(k)

Class II (US FDA 510(k))

510(k) K862684

by Boehringer Laboratories, Llc

Identifiers

510(k) Number
K862684 FDA 510(k)
FDA Product Code
CAC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5830 FDA 510(k)
Regulation Number
868.5830 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Auto-Vac Autotransfusion Reserv, Model 7900 is an apparatus designed for autotransfusion, which is the process of collecting a patient's own blood and reinfusing it during surgery or trauma procedures. This device helps to conserve blood resources and reduce the need for donor blood transfusions in appropriate clinical settings.

The device is supplied by Boehringer Laboratories, LLC and has FDA 510(k) clearance with the number K862684. It is classified as Class II medical device under product code CAC and is intended for use in anesthesiology settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the available data.

Frequently asked questions

What is the Auto-Vac Autotransfusion Reserv Model 7900 used for?

The Auto-Vac Autotransfusion Reserv Model 7900 is designed for autotransfusion, which involves collecting a patient's own blood during surgery or trauma procedures and reinfusing it to conserve blood resources and reduce the need for donor blood transfusions in appropriate clinical settings.

Who manufactures the Auto-Vac Autotransfusion Reserv Model 7900 and what is its regulatory status?

The device is manufactured by Boehringer Laboratories, LLC and has FDA 510(k) clearance under number K862684, classified as a Class II medical device under product code CAC for use in anesthesiology settings.

Is the Auto-Vac Autotransfusion Reserv Model 7900 specified as single-use or reusable, and is it sterile?

The available data does not specify whether the Auto-Vac Autotransfusion Reserv Model 7900 is single-use or reusable, and no information regarding sterility is provided in the device description or specifications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Auto-vac (Tm) Autotransfusion Reserv, Model 7900, 510(k) K862684 — AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900, Boehringer Autovac (r) 7900 Series 510 (k) FDA Premarket Notification ..., Autovac (R) Autotransfusion System, 7900 Modified, BOEHRINGER LABORATORIES, LLC FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Boehringer Laboratories, Llc
FDA Applicant
Boehringer Laboratories

Sources (1)

  • FDA 510(k) K862684 24 fields · synced Sep 24, 2026