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FDA 510(k)

ACTIVE ARRAY CATHETER, MODEL CS-2000

K-Number: K001097 · 2001-01-18

ApplicantImage-Guided Neurologics, Inc.
Decision Date2001-01-18
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACTIVE ARRAY CATHETER, MODEL CS-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Image-Guided Neurologics, Inc.. It received FDA 510(k) clearance on 2001-01-18 under 510(k) number K001097. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVE ARRAY CATHETER, MODEL CS-2000?

ACTIVE ARRAY CATHETER, MODEL CS-2000 is a medical device that received FDA 510(k) clearance on 2001-01-18. The listed applicant is Image-Guided Neurologics, Inc.. The 510(k) number is K001097.

When did ACTIVE ARRAY CATHETER, MODEL CS-2000 receive FDA 510(k) clearance?

ACTIVE ARRAY CATHETER, MODEL CS-2000 received FDA 510(k) clearance on 2001-01-18, under 510(k) number K001097.

Who is the listed applicant for ACTIVE ARRAY CATHETER, MODEL CS-2000?

The FDA 510(k) record lists Image-Guided Neurologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVE ARRAY CATHETER, MODEL CS-2000?

The FDA product code for ACTIVE ARRAY CATHETER, MODEL CS-2000 is MOS.

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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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