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FDA 510(k)

CARDIMA, INC. FORERUNNER

K-Number: K951603 · 1995-10-05

ApplicantCardima, Inc.
Decision Date1995-10-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMA, INC. FORERUNNER is the device name listed in this FDA 510(k) record. The listed applicant is Cardima, Inc.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K951603. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIMA, INC. FORERUNNER?

CARDIMA, INC. FORERUNNER is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Cardima, Inc.. The 510(k) number is K951603.

When did CARDIMA, INC. FORERUNNER receive FDA 510(k) clearance?

CARDIMA, INC. FORERUNNER received FDA 510(k) clearance on 1995-10-05, under 510(k) number K951603.

Who is the listed applicant for CARDIMA, INC. FORERUNNER?

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, INC. FORERUNNER?

The FDA product code for CARDIMA, INC. FORERUNNER is DQY.

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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: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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