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FDA 510(k)

VIEWFLEX PLUS ICE CATHETER

K-Number: K101239 · 2010-06-02

ApplicantSt Jude Medical
Decision Date2010-06-02
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIEWFLEX PLUS ICE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2010-06-02 under 510(k) number K101239. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIEWFLEX PLUS ICE CATHETER?

VIEWFLEX PLUS ICE CATHETER is a medical device that received FDA 510(k) clearance on 2010-06-02. The listed applicant is St Jude Medical. The 510(k) number is K101239.

When did VIEWFLEX PLUS ICE CATHETER receive FDA 510(k) clearance?

VIEWFLEX PLUS ICE CATHETER received FDA 510(k) clearance on 2010-06-02, under 510(k) number K101239.

Who is the listed applicant for VIEWFLEX PLUS ICE CATHETER?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIEWFLEX PLUS ICE CATHETER?

The FDA product code for VIEWFLEX PLUS ICE CATHETER is DQO.

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Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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