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FDA 510(k)

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)

K-Number: K970853 · 1997-11-04

ApplicantCardima, Inc.
Decision Date1997-11-04
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) is the device name listed in this FDA 510(k) record. The listed applicant is Cardima, Inc.. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K970853. 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 PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)?

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Cardima, Inc.. The 510(k) number is K970853.

When did PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) receive FDA 510(k) clearance?

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) received FDA 510(k) clearance on 1997-11-04, under 510(k) number K970853.

Who is the listed applicant for PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)?

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 PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)?

The FDA product code for PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) 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 DEVICEK982835ELECTRODE SWITCHBOX, MODEL 11-081002K971975CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER

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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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