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FDA 510(k)

INTRAOPERATIVE AUTOTRANSFUSION SYS

K-Number: K831557 · 1983-08-24

ApplicantThoratec Laboratories Corp.
Decision Date1983-08-24
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTRAOPERATIVE AUTOTRANSFUSION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 1983-08-24 under 510(k) number K831557. 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 INTRAOPERATIVE AUTOTRANSFUSION SYS?

INTRAOPERATIVE AUTOTRANSFUSION SYS is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K831557.

When did INTRAOPERATIVE AUTOTRANSFUSION SYS receive FDA 510(k) clearance?

INTRAOPERATIVE AUTOTRANSFUSION SYS received FDA 510(k) clearance on 1983-08-24, under 510(k) number K831557.

Who is the listed applicant for INTRAOPERATIVE AUTOTRANSFUSION SYS?

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

What is the FDA product code for INTRAOPERATIVE AUTOTRANSFUSION SYS?

The FDA product code for INTRAOPERATIVE AUTOTRANSFUSION SYS is CAC.

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Other records listing Thoratec Laboratories Corp. as applicant

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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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