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FDA 510(k)

ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

K-Number: K014016 · 2002-02-01

ApplicantMinntech Corp.
Decision Date2002-02-01
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 2002-02-01 under 510(k) number K014016. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER?

ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Minntech Corp.. The 510(k) number is K014016.

When did ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER receive FDA 510(k) clearance?

ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER received FDA 510(k) clearance on 2002-02-01, under 510(k) number K014016.

Who is the listed applicant for ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER?

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 CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER?

The FDA product code for ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER is DWC.

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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 SYSTEMK991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

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Related Devices (Code: DWC)

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.

K220635Heater-Cooler System 3TLivanova Deutschland, GmbHK212657Quantum Heater-CoolerSpectrum Medical , Ltd.K191402Heater-Cooler System 3TLivanova Deutschland, GmbHK130300HEATER-COOLER UNIT HCU 40Maquet Cardiopulmonary, AGK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip Llp

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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