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FDA 510(k)

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

K-Number: K991137 · 2000-06-08

ApplicantMinntech Corp.
Decision Date2000-06-08
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K991137. 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 ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER?

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Minntech Corp.. The 510(k) number is K991137.

When did ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER receive FDA 510(k) clearance?

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER received FDA 510(k) clearance on 2000-06-08, under 510(k) number K991137.

Who is the listed applicant for ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER?

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

What is the FDA product code for ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER?

The FDA product code for ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER is DTR.

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Other records listing Minntech Corp. 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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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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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