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FDA 510(k)

ARROW QUADPOLAR MAPPING/PACING CATHETER

K-Number: K911065 · 1992-06-18

ApplicantArrow Intl., Inc.
Decision Date1992-06-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW QUADPOLAR MAPPING/PACING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1992-06-18 under 510(k) number K911065. 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 ARROW QUADPOLAR MAPPING/PACING CATHETER?

ARROW QUADPOLAR MAPPING/PACING CATHETER is a medical device that received FDA 510(k) clearance on 1992-06-18. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K911065.

When did ARROW QUADPOLAR MAPPING/PACING CATHETER receive FDA 510(k) clearance?

ARROW QUADPOLAR MAPPING/PACING CATHETER received FDA 510(k) clearance on 1992-06-18, under 510(k) number K911065.

Who is the listed applicant for ARROW QUADPOLAR MAPPING/PACING CATHETER?

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

What is the FDA product code for ARROW QUADPOLAR MAPPING/PACING CATHETER?

The FDA product code for ARROW QUADPOLAR MAPPING/PACING CATHETER is DRF.

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Other records listing Arrow Intl., 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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