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FDA 510(k)

ELECTRODE SWITCHBOX, MODEL 11-081002

K-Number: K982835 · 1998-10-29

ApplicantCardima, Inc.
Decision Date1998-10-29
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRODE SWITCHBOX, MODEL 11-081002 is the device name listed in this FDA 510(k) record. The listed applicant is Cardima, Inc.. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K982835. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE SWITCHBOX, MODEL 11-081002?

ELECTRODE SWITCHBOX, MODEL 11-081002 is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Cardima, Inc.. The 510(k) number is K982835.

When did ELECTRODE SWITCHBOX, MODEL 11-081002 receive FDA 510(k) clearance?

ELECTRODE SWITCHBOX, MODEL 11-081002 received FDA 510(k) clearance on 1998-10-29, under 510(k) number K982835.

Who is the listed applicant for ELECTRODE SWITCHBOX, MODEL 11-081002?

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 ELECTRODE SWITCHBOX, MODEL 11-081002?

The FDA product code for ELECTRODE SWITCHBOX, MODEL 11-081002 is DRF.

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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 DEVICEK971975CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETERK973298CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER

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Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

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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