FDA 510(k)

BD Prevue II Peripheral Vascular Vascular Access System

K-Number: K211193 · 2021-06-25

ApplicantBard Access Systems, Inc. (C.R. Bard, Inc.)

Decision Date2021-06-25

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BD Prevue II Peripheral Vascular Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211193. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Prevue II Peripheral Vascular Vascular Access System?

BD Prevue II Peripheral Vascular Vascular Access System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K211193.

When did BD Prevue II Peripheral Vascular Vascular Access System receive FDA 510(k) clearance?

BD Prevue II Peripheral Vascular Vascular Access System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211193.

Who is the listed applicant for BD Prevue II Peripheral Vascular Vascular Access System?

The FDA 510(k) record lists Bard Access Systems, Inc. (C.R. Bard, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Prevue II Peripheral Vascular Vascular Access System?

The FDA product code for BD Prevue II Peripheral Vascular Vascular Access System is IYO.

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.

NCT07471555Vascular Access and IntraosseusENROLLING_BY_INVITATION NCT07512986Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing StudentsNOT_YET_RECRUITING NCT07571408Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive DiseaseNOT_YET_RECRUITING NCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentCOMPLETED NCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Bard Access Systems, Inc. (C.R. Bard, Inc.) as applicant

K233106AccuCath Ace™ Intravascular Catheter K231283SiteRite™ 9 Ultrasound System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.