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)

ProtekDilate Vascular Access Kit

K-Number: K253616 · 2025-12-19

ApplicantSorin Group Italia S.R.L.
Decision Date2025-12-19
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ProtekDilate Vascular Access Kit is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253616. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProtekDilate Vascular Access Kit?

ProtekDilate Vascular Access Kit is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K253616.

When was ProtekDilate Vascular Access Kit approved by the FDA?

ProtekDilate Vascular Access Kit received FDA 510(k) clearance on 2025-12-19, under approval number K253616.

What company makes ProtekDilate Vascular Access Kit?

ProtekDilate Vascular Access Kit is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for ProtekDilate Vascular Access Kit?

The FDA product code for ProtekDilate Vascular Access Kit is DRE.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06904651 VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery ACTIVE_NOT_RECRUITING NCT07599085 Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures NOT_YET_RECRUITING NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04484220 Ellipsys Vascular Access System Post Market Surveillance (PS) Study COMPLETED

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: DRE)

K161336VSI StraitSet micro-introducer kitVascular Solutions, Inc. K150932Sheath IntroducerBioteque Corp. K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc. K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. K162389Medcomp Vessel DilatorMedcomp ( Medical Components) K170616van Andel Dilatation CatheterCook Incorporated

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.

↑