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FDA 510(k)

INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC

K-Number: K810384 · 1981-02-13

ApplicantIntermedics, Inc.
Decision Date1981-02-13
Product Code
DecisionUnknown

Device Summary

INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-02-13 under 510(k) number K810384. FDA Decision: Unknown.

Frequently Asked Questions

What is the INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC?

INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC is a medical device that received FDA 510(k) clearance on 1981-02-13. The listed applicant is Intermedics, Inc.. The 510(k) number is K810384.

When did INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC receive FDA 510(k) clearance?

INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC received FDA 510(k) clearance on 1981-02-13, under 510(k) number K810384.

Who is the listed applicant for INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC?

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

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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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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