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)

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

K-Number: K200612 · 2020-11-17

ApplicantSorin Group Italia S.R.L.
Decision Date2020-11-17
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2020-11-17 under approval number K200612. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is a medical device that received FDA 510(k) clearance on 2020-11-17. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K200612.

When was R501 aortic root cannula without vent line, R502 aortic root cannula with vent line approved by the FDA?

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line received FDA 510(k) clearance on 2020-11-17, under approval number K200612.

What company makes R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line?

The FDA product code for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line is DWF.

Related Clinical Trials

NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT07588399 STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI NOT_YET_RECRUITING NCT07089576 Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA RECRUITING NCT07226193 Detecting Peripheral Artery Disease With the Pulse RECRUITING NCT07564050 Physiological Effects of Different Preoxygenation Strategies RECRUITING NCT07573566 Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026)

Other Devices by Sorin Group Italia S.R.L.

K162215Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C K180979PureFlex Arterial Cannulae K180411MEMO 4D K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter K190650Revolution Centrifugal Blood Pump

View all 24 devices →

Related Devices (Code: DWF)

K162214Protek Solo 24 Fr Venous Cannula SetCardiacassist, Inc. K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. K153598Medtronic Bio-Medicus Adult Cannula KitMedtronic, Inc. K171979Tubing PackMedtronic, Inc. K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 FrSurge Cardiovascular K162215Aortic Arch Cannulae, Optiflow Aortic Arch CannulaeSorin Group Italia S.R.L.

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.

↑