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FDA 510(k)

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH

K-Number: K905831 · 1991-03-29

ApplicantArzco Medical Electronics, Inc.
Decision Date1991-03-29
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH is the device name listed in this FDA 510(k) record. The listed applicant is Arzco Medical Electronics, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K905831. 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 ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH?

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Arzco Medical Electronics, Inc.. The 510(k) number is K905831.

When did ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH receive FDA 510(k) clearance?

ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH received FDA 510(k) clearance on 1991-03-29, under 510(k) number K905831.

Who is the listed applicant for ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH?

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

What is the FDA product code for ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH?

The FDA product code for ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH is DRF.

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Other records listing Arzco Medical Electronics, 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.

K904943TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPEK903136ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

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

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