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FDA 510(k)

LEAD CONVERSION KIT, MODEL 341

K-Number: K781111 · 1978-08-31

ApplicantEdwards Pacemaker Systems
Decision Date1978-08-31
Product Code
DecisionSubstantially Equivalent

Device Summary

LEAD CONVERSION KIT, MODEL 341 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Pacemaker Systems. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781111. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEAD CONVERSION KIT, MODEL 341?

LEAD CONVERSION KIT, MODEL 341 is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Edwards Pacemaker Systems. The 510(k) number is K781111.

When did LEAD CONVERSION KIT, MODEL 341 receive FDA 510(k) clearance?

LEAD CONVERSION KIT, MODEL 341 received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781111.

Who is the listed applicant for LEAD CONVERSION KIT, MODEL 341?

The FDA 510(k) record lists Edwards Pacemaker Systems as the applicant. This does not by itself establish the device manufacturer.

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 Edwards Pacemaker Systems 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.

K791751EDWARDS PACEMAKER 30 UNIPOLAR GENERATORK79045228 UNIPOLAR AND BIPOLAR PULSE GENERATORSK781144ANALYZER, PACER SYSTEM, PSA-5K781042PROLITH 23S PACEMAKERK780780MICROPULSE 22S PACEMAKERK780238PACEMAKER, PROLITH 23U. PULSE GENERATOR

View all 13 devices →

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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