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FDA 510(k)

CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS

K-Number: K873772 · 1988-10-19

ApplicantCordis Leads, Inc.
Decision Date1988-10-19
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Leads, Inc.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K873772. 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 CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS?

CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Cordis Leads, Inc.. The 510(k) number is K873772.

When did CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS receive FDA 510(k) clearance?

CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS received FDA 510(k) clearance on 1988-10-19, under 510(k) number K873772.

Who is the listed applicant for CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS?

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

What is the FDA product code for CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS?

The FDA product code for CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS is DTB.

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Other records listing Cordis Leads, 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.

K883070ENCOR UNIPOLAR VS-1 LEADSK882045HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARKK874366ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201

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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