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FDA 510(k)

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

K-Number: K010471 · 2001-06-06

ApplicantIrvine Biomedical, Inc.
Decision Date2001-06-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 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 2001-06-06 under 510(k) number K010471. 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 AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569?

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Irvine Biomedical, Inc.. The 510(k) number is K010471.

When did AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 receive FDA 510(k) clearance?

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010471.

Who is the listed applicant for AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569?

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 AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569?

The FDA product code for AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 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.

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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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