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FDA 510(k)

CARDIMA TRACKER(R) INFUSION CATHETER

K-Number: K932800 · 1993-12-21

ApplicantCardima, Inc.
Decision Date1993-12-21
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIMA TRACKER(R) INFUSION 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 1993-12-21 under 510(k) number K932800. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIMA TRACKER(R) INFUSION CATHETER?

CARDIMA TRACKER(R) INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1993-12-21. The listed applicant is Cardima, Inc.. The 510(k) number is K932800.

When did CARDIMA TRACKER(R) INFUSION CATHETER receive FDA 510(k) clearance?

CARDIMA TRACKER(R) INFUSION CATHETER received FDA 510(k) clearance on 1993-12-21, under 510(k) number K932800.

Who is the listed applicant for CARDIMA TRACKER(R) INFUSION 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 CARDIMA TRACKER(R) INFUSION CATHETER?

The FDA product code for CARDIMA TRACKER(R) INFUSION CATHETER is KRA.

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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: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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