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FDA 510(k)

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

K-Number: K031164 · 2003-06-19

ApplicantOscor, Inc.
Decision Date2003-06-19
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K031164. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV?

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is Oscor, Inc.. The 510(k) number is K031164.

When did PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV receive FDA 510(k) clearance?

PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV received FDA 510(k) clearance on 2003-06-19, under 510(k) number K031164.

Who is the listed applicant for PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV?

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 PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV?

The FDA product code for PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV is DTD.

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Related Devices (Code: DTD)

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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.

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