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FDA 510(k)

PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM

K-Number: K120953 · 2012-12-10

ApplicantTlelflex Medical, Inc.
Decision Date2012-12-10
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tlelflex Medical, Inc.. It received FDA 510(k) clearance on 2012-12-10 under 510(k) number K120953. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM?

PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-10. The listed applicant is Tlelflex Medical, Inc.. The 510(k) number is K120953.

When did PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 2012-12-10, under 510(k) number K120953.

Who is the listed applicant for PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM?

The FDA product code for PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM is CAC.

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Related Devices (Code: CAC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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