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FDA 510(k)

HARMAC QUADPOLAR MAPPING PACING CATHETER

K-Number: K963074 · 1997-06-25

ApplicantHarmac Medical Products, Inc.
Decision Date1997-06-25
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARMAC QUADPOLAR MAPPING PACING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Harmac Medical Products, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K963074. 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 HARMAC QUADPOLAR MAPPING PACING CATHETER?

HARMAC QUADPOLAR MAPPING PACING CATHETER is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Harmac Medical Products, Inc.. The 510(k) number is K963074.

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

HARMAC QUADPOLAR MAPPING PACING CATHETER received FDA 510(k) clearance on 1997-06-25, under 510(k) number K963074.

Who is the listed applicant for HARMAC QUADPOLAR MAPPING PACING CATHETER?

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

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

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

Related Clinical Trials

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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Other records listing Harmac Medical Products, 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.

K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001K962829HARMAC BALLOON ANGIOGRAPHIC CATHETERK963335HARMAC BALLOON WEDGE PRESSURE CATHETERK962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONK963336HARMAC THERMODILUTION CATHETERK963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET

View all 8 devices →

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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