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FDA 510(k)

AUTOTRANSFUSION SUCTION SET

K-Number: K920618 · 1993-03-12

ApplicantLifestream Int'L, Inc.
Decision Date1993-03-12
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOTRANSFUSION SUCTION SET is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1993-03-12 under 510(k) number K920618. 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 AUTOTRANSFUSION SUCTION SET?

AUTOTRANSFUSION SUCTION SET is a medical device that received FDA 510(k) clearance on 1993-03-12. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K920618.

When did AUTOTRANSFUSION SUCTION SET receive FDA 510(k) clearance?

AUTOTRANSFUSION SUCTION SET received FDA 510(k) clearance on 1993-03-12, under 510(k) number K920618.

Who is the listed applicant for AUTOTRANSFUSION SUCTION SET?

The FDA 510(k) record lists Lifestream Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOTRANSFUSION SUCTION SET?

The FDA product code for AUTOTRANSFUSION SUCTION SET is CAC.

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Other records listing Lifestream Int'L, Inc. as applicant

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.

K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERSK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST

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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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