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FDA 510(k)

IMPLANTABLE VENTRICULAR-INHIBITED CARDI

K-Number: K802175 · 1981-02-05

ApplicantTelectronics, Inc.
Decision Date1981-02-05
Product Code
DecisionSubstantially Equivalent

Device Summary

IMPLANTABLE VENTRICULAR-INHIBITED CARDI is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K802175. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTABLE VENTRICULAR-INHIBITED CARDI?

IMPLANTABLE VENTRICULAR-INHIBITED CARDI is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Telectronics, Inc.. The 510(k) number is K802175.

When did IMPLANTABLE VENTRICULAR-INHIBITED CARDI receive FDA 510(k) clearance?

IMPLANTABLE VENTRICULAR-INHIBITED CARDI received FDA 510(k) clearance on 1981-02-05, under 510(k) number K802175.

Who is the listed applicant for IMPLANTABLE VENTRICULAR-INHIBITED CARDI?

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

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Other records listing Telectronics, Inc. as applicant

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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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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.

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