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FDA 510(k)

BAYLOR RAPID AUTOTRANSFUSION SYSTEM

K-Number: K852736 · 1985-09-18

ApplicantCardio Systems, Inc.
Decision Date1985-09-18
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BAYLOR RAPID AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K852736. 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 BAYLOR RAPID AUTOTRANSFUSION SYSTEM?

BAYLOR RAPID AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K852736.

When did BAYLOR RAPID AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

BAYLOR RAPID AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852736.

Who is the listed applicant for BAYLOR RAPID AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for BAYLOR RAPID AUTOTRANSFUSION SYSTEM?

The FDA product code for BAYLOR RAPID 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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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