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FDA 510(k)

SiteRite™ 9 Ultrasound System

K-Number: K231283 · 2023-09-11

ApplicantBard Access Systems, Inc. (C.R. Bard, Inc.)
Decision Date2023-09-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SiteRite™ 9 Ultrasound 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 2023-09-11 under 510(k) number K231283. 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 SiteRite™ 9 Ultrasound System?

SiteRite™ 9 Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-09-11. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K231283.

When did SiteRite™ 9 Ultrasound System receive FDA 510(k) clearance?

SiteRite™ 9 Ultrasound System received FDA 510(k) clearance on 2023-09-11, under 510(k) number K231283.

Who is the listed applicant for SiteRite™ 9 Ultrasound 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 SiteRite™ 9 Ultrasound System?

The FDA product code for SiteRite™ 9 Ultrasound System is IYO.

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

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.

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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.

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