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FDA 510(k)

CARDIMA SEEKER AND STUBBIE GUIDEWIRES

K-Number: K932801 · 1993-09-01

ApplicantCardima, Inc.
Decision Date1993-09-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMA SEEKER AND STUBBIE GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Cardima, Inc.. It received FDA 510(k) clearance on 1993-09-01 under 510(k) number K932801. 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 CARDIMA SEEKER AND STUBBIE GUIDEWIRES?

CARDIMA SEEKER AND STUBBIE GUIDEWIRES is a medical device that received FDA 510(k) clearance on 1993-09-01. The listed applicant is Cardima, Inc.. The 510(k) number is K932801.

When did CARDIMA SEEKER AND STUBBIE GUIDEWIRES receive FDA 510(k) clearance?

CARDIMA SEEKER AND STUBBIE GUIDEWIRES received FDA 510(k) clearance on 1993-09-01, under 510(k) number K932801.

Who is the listed applicant for CARDIMA SEEKER AND STUBBIE GUIDEWIRES?

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

What is the FDA product code for CARDIMA SEEKER AND STUBBIE GUIDEWIRES?

The FDA product code for CARDIMA SEEKER AND STUBBIE GUIDEWIRES is DQX.

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Other records listing Cardima, 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.

K060715MODIFICATION TO: CARDIMA ABLATION SYSTEMK022008CARDIMA ABLATION SYSTEMK974683NAVIPORT DEFLECTABLE TIP GUIDING CATHETERK972803TRACER O-T-W MAPPING DEVICEK982835ELECTRODE SWITCHBOX, MODEL 11-081002K971975CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER

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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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