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)

SIRECUST 358

K-Number: K803208 · 1981-05-27

ApplicantSiemens Corp.
Decision Date1981-05-27
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIRECUST 358 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K803208. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIRECUST 358?

SIRECUST 358 is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Siemens Corp.. The 510(k) number is K803208.

When did SIRECUST 358 receive FDA 510(k) clearance?

SIRECUST 358 received FDA 510(k) clearance on 1981-05-27, under 510(k) number K803208.

Who is the listed applicant for SIRECUST 358?

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

What is the FDA product code for SIRECUST 358?

The FDA product code for SIRECUST 358 is DSI.

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 Siemens 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.

K103360DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CALK993947KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILYK992925AX WORKSTATION DR-VIEWER SOFTWARE OPTIONK991652HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEMK991600SOMATOM PLUS 4 WITH SLIDING GANTRY OPTIONK984221FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR

View all 66 devices →

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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.

↑