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FDA 510(k)

UNIPOPLAR ENDOCARDIAL LEADS

K-Number: K781326 · 1978-12-04

ApplicantAmerican Technology, Inc.
Decision Date1978-12-04
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIPOPLAR ENDOCARDIAL LEADS is the device name listed in this FDA 510(k) record. The listed applicant is American Technology, Inc.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781326. 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 UNIPOPLAR ENDOCARDIAL LEADS?

UNIPOPLAR ENDOCARDIAL LEADS is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is American Technology, Inc.. The 510(k) number is K781326.

When did UNIPOPLAR ENDOCARDIAL LEADS receive FDA 510(k) clearance?

UNIPOPLAR ENDOCARDIAL LEADS received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781326.

Who is the listed applicant for UNIPOPLAR ENDOCARDIAL LEADS?

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

What is the FDA product code for UNIPOPLAR ENDOCARDIAL LEADS?

The FDA product code for UNIPOPLAR ENDOCARDIAL LEADS is DTB.

Related Clinical Trials

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.

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Other records listing American Technology, 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.

K781456ENDOCARDIAL BIPOLAR LEADK771528CATHETER, CARDIAC PACING, ENDOCARDIAL

Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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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