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 a medical device manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2023-09-11 under approval 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. It is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K231283.

When was SiteRite 9 Ultrasound System approved by the FDA?

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

What company makes SiteRite 9 Ultrasound System?

SiteRite 9 Ultrasound System is manufactured by Bard Access Systems, Inc. (C.R. Bard, Inc.).

What is the FDA product code for SiteRite 9 Ultrasound System?

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

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

K211193BD Prevue II Peripheral Vascular Vascular Access System K233106AccuCath Ace Intravascular Catheter

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.