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FDA 510(k)

LUMA-CATH STEERABLE EP CATHETERS

K-Number: K991878 · 1999-12-10

ApplicantIrvine Biomedical, Inc.
Decision Date1999-12-10
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUMA-CATH STEERABLE EP CATHETERS 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 1999-12-10 under 510(k) number K991878. 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 LUMA-CATH STEERABLE EP CATHETERS?

LUMA-CATH STEERABLE EP CATHETERS is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is Irvine Biomedical, Inc.. The 510(k) number is K991878.

When did LUMA-CATH STEERABLE EP CATHETERS receive FDA 510(k) clearance?

LUMA-CATH STEERABLE EP CATHETERS received FDA 510(k) clearance on 1999-12-10, under 510(k) number K991878.

Who is the listed applicant for LUMA-CATH STEERABLE EP CATHETERS?

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 LUMA-CATH STEERABLE EP CATHETERS?

The FDA product code for LUMA-CATH STEERABLE EP CATHETERS 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 CATHETERK042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERK010471AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569K991025LUMA-CATH FIXED CURVE EP CATHETERS

View all 11 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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