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FDA 510(k)

HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER

K-Number: K932388 · 1995-05-31

ApplicantHeart Rhythm Technologies, Inc.
Decision Date1995-05-31
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Heart Rhythm Technologies, Inc.. It received FDA 510(k) clearance on 1995-05-31 under 510(k) number K932388. 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 HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER?

HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 1995-05-31. The listed applicant is Heart Rhythm Technologies, Inc.. The 510(k) number is K932388.

When did HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?

HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 1995-05-31, under 510(k) number K932388.

Who is the listed applicant for HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER?

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

What is the FDA product code for HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER?

The FDA product code for HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER is DRF.

Related Clinical Trials

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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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