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FDA 510(k)

NAVIPORT DEFLECTABLE TIP GUIDING CATHETER

K-Number: K974683 · 1999-06-22

ApplicantCardima, Inc.
Decision Date1999-06-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NAVIPORT DEFLECTABLE TIP GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardima, Inc.. It received FDA 510(k) clearance on 1999-06-22 under 510(k) number K974683. 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 NAVIPORT DEFLECTABLE TIP GUIDING CATHETER?

NAVIPORT DEFLECTABLE TIP GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 1999-06-22. The listed applicant is Cardima, Inc.. The 510(k) number is K974683.

When did NAVIPORT DEFLECTABLE TIP GUIDING CATHETER receive FDA 510(k) clearance?

NAVIPORT DEFLECTABLE TIP GUIDING CATHETER received FDA 510(k) clearance on 1999-06-22, under 510(k) number K974683.

Who is the listed applicant for NAVIPORT DEFLECTABLE TIP GUIDING CATHETER?

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 NAVIPORT DEFLECTABLE TIP GUIDING CATHETER?

The FDA product code for NAVIPORT DEFLECTABLE TIP GUIDING CATHETER 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 SYSTEMK972803TRACER O-T-W MAPPING DEVICEK982835ELECTRODE SWITCHBOX, MODEL 11-081002K971975CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETERK973298CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER

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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, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus 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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