FDA 510(k)

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS

K-Number: K884811 · 1989-02-22

ApplicantTelectronics and Control Pacing Systems

Decision Date1989-02-22

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics and Control Pacing Systems. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K884811. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS?

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Telectronics and Control Pacing Systems. The 510(k) number is K884811.

When did ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS receive FDA 510(k) clearance?

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS received FDA 510(k) clearance on 1989-02-22, under 510(k) number K884811.

Who is the listed applicant for ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS?

The FDA 510(k) record lists Telectronics and Control Pacing Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS?

The FDA product code for ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS is DTB.

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Related Devices (Code: DTB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.