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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. It received FDA 510(k) clearance on 2021-06-16 under 510(k) 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. The listed applicant is Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. The 510(k) number is K211044.

When did Sublime Radial Access 018 RX Dilatation Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Sublime Radial Access 018 RX Dilatation Catheter?

The FDA 510(k) record lists Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07762560Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic ShockNOT_YET_RECRUITING

Related Devices (Code: LIT)

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.

K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, Inc.K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K241040Amethyst HP PTA OTW 0.035 CatheterNatec 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.

↑