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FDA 510(k)

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE

K-Number: K030019 · 2003-01-24

ApplicantGuidant Corp.
Decision Date2003-01-24
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K030019. 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 MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE?

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Guidant Corp.. The 510(k) number is K030019.

When did MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE receive FDA 510(k) clearance?

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE received FDA 510(k) clearance on 2003-01-24, under 510(k) number K030019.

Who is the listed applicant for MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE?

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

What is the FDA product code for MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE?

The FDA product code for MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE is DQX.

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Other records listing Guidant Corp. 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.

K061865FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05K061453HI-TORQUE WHISPER VIEW GUIDE WIREK042908RX ACCUNET 2 EMBOLIC PROTECTION SYSTEMK042218ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEMK033834OMNILINK .018 BILIARY STENT SYSTEMK033393ABSOLUTE .035 SELF-EXPANDING BILIARY STENT 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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