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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 a medical device manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2021-06-25 under approval 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. It is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K211193.

When was BD Prevue II Peripheral Vascular Vascular Access System approved by the FDA?

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

What company makes BD Prevue II Peripheral Vascular Vascular Access System?

BD Prevue II Peripheral Vascular Vascular Access System is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.).

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.

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Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Bard Access Systems, Inc. (C.R. Bard, Inc.)

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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.

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