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

FDA 510(k)

Tri-Ad 2.0 Adams Tricuspid Band

K-Number: K181132 · 2018-05-29

ApplicantMedtronic
Decision Date2018-05-29
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tri-Ad 2.0 Adams Tricuspid Band is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2018-05-29 under approval number K181132. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tri-Ad 2.0 Adams Tricuspid Band?

Tri-Ad 2.0 Adams Tricuspid Band is a medical device that received FDA 510(k) clearance on 2018-05-29. It is manufactured by Medtronic. The 510(k) number is K181132.

When was Tri-Ad 2.0 Adams Tricuspid Band approved by the FDA?

Tri-Ad 2.0 Adams Tricuspid Band received FDA 510(k) clearance on 2018-05-29, under approval number K181132.

What company makes Tri-Ad 2.0 Adams Tricuspid Band?

Tri-Ad 2.0 Adams Tricuspid Band is manufactured by Medtronic.

What is the FDA product code for Tri-Ad 2.0 Adams Tricuspid Band?

The FDA product code for Tri-Ad 2.0 Adams Tricuspid Band is KRH.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT06059638 BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT05149755 Evolut™ EXPAND TAVR II Pivotal Trial ACTIVE_NOT_RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT03546374 Medtronic Terminate AF Study RECRUITING

Other Devices by Medtronic

K161249Streamline 6495 Bipolar Temporary Myocardial Pacing Lead K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set K171253Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead K182610Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device K191851VS3-IR K190716Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead

View all 26 devices →

Related Devices (Code: KRH)

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. K180411MEMO 4DSorin Group Italia S.R.L. K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc. K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty RingMedtronic, Inc.

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.

↑