FDA 510(k)

ENCOR UNIPOLAR VS-1 LEADS

K-Number: K883070 · 1988-12-05

Decision Date1988-12-05

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ENCOR UNIPOLAR VS-1 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 1988-12-05 under 510(k) number K883070. 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 ENCOR UNIPOLAR VS-1 LEADS?

ENCOR UNIPOLAR VS-1 LEADS is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Cordis Leads, Inc.. The 510(k) number is K883070.

When did ENCOR UNIPOLAR VS-1 LEADS receive FDA 510(k) clearance?

ENCOR UNIPOLAR VS-1 LEADS received FDA 510(k) clearance on 1988-12-05, under 510(k) number K883070.

Who is the listed applicant for ENCOR UNIPOLAR VS-1 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 ENCOR UNIPOLAR VS-1 LEADS?

The FDA product code for ENCOR UNIPOLAR VS-1 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 Cordis Leads, Inc. as applicant

K873772CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS K882045HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK K874366ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201

Related Devices (Code: DTB)

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 Vascular K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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.