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FDA 510(k)

RADIONICS RF DISC CATHETER ELECTRODE SYSTEM

K-Number: K001741 · 2000-10-23

ApplicantRadionics, Inc.
Decision Date2000-10-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RADIONICS RF DISC CATHETER ELECTRODE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 2000-10-23 under 510(k) number K001741. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS RF DISC CATHETER ELECTRODE SYSTEM?

RADIONICS RF DISC CATHETER ELECTRODE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-10-23. The listed applicant is Radionics, Inc.. The 510(k) number is K001741.

When did RADIONICS RF DISC CATHETER ELECTRODE SYSTEM receive FDA 510(k) clearance?

RADIONICS RF DISC CATHETER ELECTRODE SYSTEM received FDA 510(k) clearance on 2000-10-23, under 510(k) number K001741.

Who is the listed applicant for RADIONICS RF DISC CATHETER ELECTRODE SYSTEM?

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

What is the FDA product code for RADIONICS RF DISC CATHETER ELECTRODE SYSTEM?

The FDA product code for RADIONICS RF DISC CATHETER ELECTRODE SYSTEM is HRX.

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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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