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)

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)

K-Number: K103168 · 2011-01-06

ApplicantSorin Group Deutschland GmbH
Decision Date2011-01-06
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Deutschland GmbH. It received FDA 510(k) clearance on 2011-01-06 under 510(k) number K103168. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)?

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Sorin Group Deutschland GmbH. The 510(k) number is K103168.

When did B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) receive FDA 510(k) clearance?

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) received FDA 510(k) clearance on 2011-01-06, under 510(k) number K103168.

Who is the listed applicant for B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)?

The FDA 510(k) record lists Sorin Group Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)?

The FDA product code for B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) is DRY.

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 Sorin Group Deutschland GmbH 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.

K170460Sorin ConnectK131816SORIN CONNECT DATA MANAGEMENT SYSTEMK112225SORIN CENTRIFUGAL PUMP 5 (CP5)K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLEK103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

View all 18 devices →

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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.

↑