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FDA 510(k)

FLOWPICC CONSOLE

K-Number: K081626 · 2008-10-15

ApplicantVasonova, Inc.
Decision Date2008-10-15
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWPICC CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Vasonova, Inc.. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K081626. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWPICC CONSOLE?

FLOWPICC CONSOLE is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Vasonova, Inc.. The 510(k) number is K081626.

When did FLOWPICC CONSOLE receive FDA 510(k) clearance?

FLOWPICC CONSOLE received FDA 510(k) clearance on 2008-10-15, under 510(k) number K081626.

Who is the listed applicant for FLOWPICC CONSOLE?

The FDA 510(k) record lists Vasonova, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOWPICC CONSOLE?

The FDA product code for FLOWPICC CONSOLE is OBJ.

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Other records listing Vasonova, 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.

K123813VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLEK103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETK103260VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLEK091924VPS CATHETERK083920FLOWPICC CATHETERK082481FLOWPICC CATHETER

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Related Devices (Code: OBJ)

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.

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.

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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