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FDA 510(k)

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER

K-Number: K042775 · 2004-11-04

ApplicantIrvine Biomedical, Inc.
Decision Date2004-11-04
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical, Inc.. It received FDA 510(k) clearance on 2004-11-04 under 510(k) number K042775. 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 INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER?

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER is a medical device that received FDA 510(k) clearance on 2004-11-04. The listed applicant is Irvine Biomedical, Inc.. The 510(k) number is K042775.

When did INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER receive FDA 510(k) clearance?

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER received FDA 510(k) clearance on 2004-11-04, under 510(k) number K042775.

Who is the listed applicant for INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER?

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

What is the FDA product code for INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER?

The FDA product code for INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER is DRF.

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Other records listing Irvine Biomedical, 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.

K082061INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETERK060757INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETERK053582INQUIRY AFOCUS II DIAGNOSTIC CATHETERK010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569K991878LUMA-CATH STEERABLE EP CATHETERSK991025LUMA-CATH FIXED CURVE EP CATHETERS

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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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