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FDA 510(k)

THEROX INFUSION GUIDEWIRES

K-Number: K971719 · 1997-11-03

ApplicantTherox, Inc.
Decision Date1997-11-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THEROX INFUSION GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Therox, Inc.. It received FDA 510(k) clearance on 1997-11-03 under 510(k) number K971719. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEROX INFUSION GUIDEWIRES?

THEROX INFUSION GUIDEWIRES is a medical device that received FDA 510(k) clearance on 1997-11-03. The listed applicant is Therox, Inc.. The 510(k) number is K971719.

When did THEROX INFUSION GUIDEWIRES receive FDA 510(k) clearance?

THEROX INFUSION GUIDEWIRES received FDA 510(k) clearance on 1997-11-03, under 510(k) number K971719.

Who is the listed applicant for THEROX INFUSION GUIDEWIRES?

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

What is the FDA product code for THEROX INFUSION GUIDEWIRES?

The FDA product code for THEROX INFUSION GUIDEWIRES is DQX.

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 Therox, 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.

K052637THEROX INFUSION CATHETER, MODEL INCA-1

Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., 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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