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FDA 510(k)

CARDIOTOMY RESERVOIR W/20 MICRON FILITER

K-Number: K920178 · 1993-05-13

ApplicantLifestream Int'L, Inc.
Decision Date1993-05-13
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR W/20 MICRON FILITER 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 1993-05-13 under 510(k) number K920178. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTOMY RESERVOIR W/20 MICRON FILITER?

CARDIOTOMY RESERVOIR W/20 MICRON FILITER is a medical device that received FDA 510(k) clearance on 1993-05-13. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K920178.

When did CARDIOTOMY RESERVOIR W/20 MICRON FILITER receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR W/20 MICRON FILITER received FDA 510(k) clearance on 1993-05-13, under 510(k) number K920178.

Who is the listed applicant for CARDIOTOMY RESERVOIR W/20 MICRON FILITER?

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 CARDIOTOMY RESERVOIR W/20 MICRON FILITER?

The FDA product code for CARDIOTOMY RESERVOIR W/20 MICRON FILITER is DTN.

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

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K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920618AUTOTRANSFUSION SUCTION SETK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERSK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST

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Related Devices (Code: DTN)

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

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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