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FDA 510(k)

VISION CARDIOPLEGIA DELIVERY SYSTEM

K-Number: K964571 · 1997-08-08

ApplicantLifestream Int'L, Inc.
Decision Date1997-08-08
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VISION CARDIOPLEGIA DELIVERY SYSTEM 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 1997-08-08 under 510(k) number K964571. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISION CARDIOPLEGIA DELIVERY SYSTEM?

VISION CARDIOPLEGIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-08. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K964571.

When did VISION CARDIOPLEGIA DELIVERY SYSTEM receive FDA 510(k) clearance?

VISION CARDIOPLEGIA DELIVERY SYSTEM received FDA 510(k) clearance on 1997-08-08, under 510(k) number K964571.

Who is the listed applicant for VISION CARDIOPLEGIA DELIVERY SYSTEM?

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 VISION CARDIOPLEGIA DELIVERY SYSTEM?

The FDA product code for VISION CARDIOPLEGIA DELIVERY SYSTEM is DTR.

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

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Related Devices (Code: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

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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