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)

CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT

K-Number: K970638 · 1997-10-30

ApplicantCardiothoracic Systems, Inc.
Decision Date1997-10-30
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 1997-10-30 under 510(k) number K970638. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT?

CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT is a medical device that received FDA 510(k) clearance on 1997-10-30. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K970638.

When did CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT receive FDA 510(k) clearance?

CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT received FDA 510(k) clearance on 1997-10-30, under 510(k) number K970638.

Who is the listed applicant for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT?

The FDA 510(k) record lists Cardiothoracic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT?

The FDA product code for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT is DXC.

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 Cardiothoracic Systems, Inc. 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.

K010117GUIDANT AXIUS CORONARY SHUNTK983270VOYAGER QUAD CANNULAK982419HEART-LIFT BALLOON POSITIONERK983135BLOWER/MISTERK963965CTS MIDCAB STITCHERK963503CTS MIDCAB CORONARY SHUNT

View all 8 devices →

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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.

↑