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FDA 510(k)

RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER

K-Number: K082736 · 2008-09-24

ApplicantTerumo Medical Corp.
Decision Date2008-09-24
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2008-09-24 under 510(k) number K082736. 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 RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER?

RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 2008-09-24. The listed applicant is Terumo Medical Corp.. The 510(k) number is K082736.

When did RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 2008-09-24, under 510(k) number K082736.

Who is the listed applicant for RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER?

The FDA product code for RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER is DQO.

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Other records listing Terumo Medical Corp. as applicant

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K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

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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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