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FDA 510(k)

MAPPING PROBE MODEL #6540

K-Number: K802058 · 1980-11-19

ApplicantCardiac Pacemakers, Inc.
Decision Date1980-11-19
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAPPING PROBE MODEL #6540 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1980-11-19 under 510(k) number K802058. 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 MAPPING PROBE MODEL #6540?

MAPPING PROBE MODEL #6540 is a medical device that received FDA 510(k) clearance on 1980-11-19. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K802058.

When did MAPPING PROBE MODEL #6540 receive FDA 510(k) clearance?

MAPPING PROBE MODEL #6540 received FDA 510(k) clearance on 1980-11-19, under 510(k) number K802058.

Who is the listed applicant for MAPPING PROBE MODEL #6540?

The FDA 510(k) record lists Cardiac Pacemakers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAPPING PROBE MODEL #6540?

The FDA product code for MAPPING PROBE MODEL #6540 is DRF.

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Other records listing Cardiac Pacemakers, Inc. as applicant

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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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