Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEATER-COOLER UNIT HCU 40

K-Number: K130300 · 2013-07-01

ApplicantMaquet Cardiopulmonary, AG
Decision Date2013-07-01
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEATER-COOLER UNIT HCU 40 is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2013-07-01 under 510(k) number K130300. 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 HEATER-COOLER UNIT HCU 40?

HEATER-COOLER UNIT HCU 40 is a medical device that received FDA 510(k) clearance on 2013-07-01. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K130300.

When did HEATER-COOLER UNIT HCU 40 receive FDA 510(k) clearance?

HEATER-COOLER UNIT HCU 40 received FDA 510(k) clearance on 2013-07-01, under 510(k) number K130300.

Who is the listed applicant for HEATER-COOLER UNIT HCU 40?

The FDA 510(k) record lists Maquet Cardiopulmonary, AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEATER-COOLER UNIT HCU 40?

The FDA product code for HEATER-COOLER UNIT HCU 40 is DWC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Maquet Cardiopulmonary, AG 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.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK123288HEMOCONCENTRATORK130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

View all 40 devices →

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, GmbHK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.K102147CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000Cardioquip LlpK071521TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEMTerumo Cardiovascular Systems Corp.

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.

↑