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FDA 510(k)

COMBOMAP PRESSURE AND FLOW SYSTEM

K-Number: K041134 · 2004-06-02

ApplicantVolcano Therapeutics, Inc.
Decision Date2004-06-02
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMBOMAP PRESSURE AND FLOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Therapeutics, Inc.. It received FDA 510(k) clearance on 2004-06-02 under 510(k) number K041134. 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 COMBOMAP PRESSURE AND FLOW SYSTEM?

COMBOMAP PRESSURE AND FLOW SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-02. The listed applicant is Volcano Therapeutics, Inc.. The 510(k) number is K041134.

When did COMBOMAP PRESSURE AND FLOW SYSTEM receive FDA 510(k) clearance?

COMBOMAP PRESSURE AND FLOW SYSTEM received FDA 510(k) clearance on 2004-06-02, under 510(k) number K041134.

Who is the listed applicant for COMBOMAP PRESSURE AND FLOW SYSTEM?

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

What is the FDA product code for COMBOMAP PRESSURE AND FLOW SYSTEM?

The FDA product code for COMBOMAP PRESSURE AND FLOW SYSTEM is OBJ.

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.

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Other records listing Volcano Therapeutics, 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.

K042996COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIREK042188VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM

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

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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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