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FDA 510(k)

WIRE, GUIDE, CATHETER, MODEL QSW1000

K-Number: K002346 · 2000-09-27

ApplicantMedtronic Ave, Inc.
Decision Date2000-09-27
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRE, GUIDE, CATHETER, MODEL QSW1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Ave, Inc.. It received FDA 510(k) clearance on 2000-09-27 under 510(k) number K002346. 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 WIRE, GUIDE, CATHETER, MODEL QSW1000?

WIRE, GUIDE, CATHETER, MODEL QSW1000 is a medical device that received FDA 510(k) clearance on 2000-09-27. The listed applicant is Medtronic Ave, Inc.. The 510(k) number is K002346.

When did WIRE, GUIDE, CATHETER, MODEL QSW1000 receive FDA 510(k) clearance?

WIRE, GUIDE, CATHETER, MODEL QSW1000 received FDA 510(k) clearance on 2000-09-27, under 510(k) number K002346.

Who is the listed applicant for WIRE, GUIDE, CATHETER, MODEL QSW1000?

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

What is the FDA product code for WIRE, GUIDE, CATHETER, MODEL QSW1000?

The FDA product code for WIRE, GUIDE, CATHETER, MODEL QSW1000 is DQX.

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Other records listing Medtronic Ave, 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.

K032768MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)K030633MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANTK030839MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)K022026MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)K014205MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)K011080BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM

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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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