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FDA 510(k)

THE PROMPT GUIDWIRE

K-Number: K943522 · 1994-12-19

ApplicantCordis Corp.
Decision Date1994-12-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE PROMPT GUIDWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1994-12-19 under 510(k) number K943522. 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 THE PROMPT GUIDWIRE?

THE PROMPT GUIDWIRE is a medical device that received FDA 510(k) clearance on 1994-12-19. The listed applicant is Cordis Corp.. The 510(k) number is K943522.

When did THE PROMPT GUIDWIRE receive FDA 510(k) clearance?

THE PROMPT GUIDWIRE received FDA 510(k) clearance on 1994-12-19, under 510(k) number K943522.

Who is the listed applicant for THE PROMPT GUIDWIRE?

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

What is the FDA product code for THE PROMPT GUIDWIRE?

The FDA product code for THE PROMPT GUIDWIRE is DQX.

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Other records listing Cordis 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.

K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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