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)

Sublime Radial Access 018 RX Dilatation Catheter

K-Number: K211044 · 2021-06-16

ApplicantCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,
Decision Date2021-06-16
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sublime Radial Access 018 RX Dilatation Catheter is a medical device manufactured by Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. It received FDA 510(k) clearance on 2021-06-16 under approval number K211044. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sublime Radial Access 018 RX Dilatation Catheter?

Sublime Radial Access 018 RX Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-06-16. It is manufactured by Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. The 510(k) number is K211044.

When was Sublime Radial Access 018 RX Dilatation Catheter approved by the FDA?

Sublime Radial Access 018 RX Dilatation Catheter received FDA 510(k) clearance on 2021-06-16, under approval number K211044.

What company makes Sublime Radial Access 018 RX Dilatation Catheter?

Sublime Radial Access 018 RX Dilatation Catheter is manufactured by Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,.

What is the FDA product code for Sublime Radial Access 018 RX Dilatation Catheter?

The FDA product code for Sublime Radial Access 018 RX Dilatation Catheter is LIT.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT06487273 Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis RECRUITING

Related Devices (Code: LIT)

K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K162316Pirouette 014Arravasc, Ltd. K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018Boston Scientific Corporation K161427Pirouette 035Arravasc Limited K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160004Crosstella OTWKANEKA Corporation

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.

↑