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FDA 510(k)

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

K-Number: K961924 · 1997-04-11

ApplicantIrvine Biomedical, Inc.
Decision Date1997-04-11
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM 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 1997-04-11 under 510(k) number K961924. 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-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM?

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Irvine Biomedical, Inc.. The 510(k) number is K961924.

When did IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM receive FDA 510(k) clearance?

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM received FDA 510(k) clearance on 1997-04-11, under 510(k) number K961924.

Who is the listed applicant for IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM?

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-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM?

The FDA product code for IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM 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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