FDA 510(k)

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)

K-Number: K072770 · 2008-01-22

Decision Date2008-01-22

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2008-01-22 under 510(k) number K072770. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)?

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) is a medical device that received FDA 510(k) clearance on 2008-01-22. The listed applicant is Oscor, Inc.. The 510(k) number is K072770.

When did TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) receive FDA 510(k) clearance?

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) received FDA 510(k) clearance on 2008-01-22, under 510(k) number K072770.

Who is the listed applicant for TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)?

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

What is the FDA product code for TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)?

The FDA product code for TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) is LDF.

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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.