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FDA 510(k)

CATHETER, CARDIAC PACING, ENDOCARDIAL

K-Number: K771528 · 1977-08-16

ApplicantAmerican Technology, Inc.
Decision Date1977-08-16
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, CARDIAC PACING, ENDOCARDIAL 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 1977-08-16 under 510(k) number K771528. 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 CATHETER, CARDIAC PACING, ENDOCARDIAL?

CATHETER, CARDIAC PACING, ENDOCARDIAL is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is American Technology, Inc.. The 510(k) number is K771528.

When did CATHETER, CARDIAC PACING, ENDOCARDIAL receive FDA 510(k) clearance?

CATHETER, CARDIAC PACING, ENDOCARDIAL received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771528.

Who is the listed applicant for CATHETER, CARDIAC PACING, ENDOCARDIAL?

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 CATHETER, CARDIAC PACING, ENDOCARDIAL?

The FDA product code for CATHETER, CARDIAC PACING, ENDOCARDIAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 LEADK781326UNIPOPLAR ENDOCARDIAL LEADS

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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