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FDA 510(k)

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER

K-Number: K946333 · 1995-07-18

ApplicantIrvine Biomedical, Inc.
Decision Date1995-07-18
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER 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 1995-07-18 under 510(k) number K946333. 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 IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER?

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER is a medical device that received FDA 510(k) clearance on 1995-07-18. The listed applicant is Irvine Biomedical, Inc.. The 510(k) number is K946333.

When did IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER receive FDA 510(k) clearance?

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER received FDA 510(k) clearance on 1995-07-18, under 510(k) number K946333.

Who is the listed applicant for IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER?

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 IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER?

The FDA product code for IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER is DRF.

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Other records listing Irvine Biomedical, Inc. as applicant

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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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