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FDA 510(k)

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

K-Number: K033858 · 2004-07-12

Decision Date2004-07-12
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE is the device name listed in this FDA 510(k) record. The listed applicant is European Custom Manufacturing BV. It received FDA 510(k) clearance on 2004-07-12 under 510(k) number K033858. 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 BIPOLAR MYOCARDIAL PACING WIRE?

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE is a medical device that received FDA 510(k) clearance on 2004-07-12. The listed applicant is European Custom Manufacturing BV. The 510(k) number is K033858.

When did TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE receive FDA 510(k) clearance?

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE received FDA 510(k) clearance on 2004-07-12, under 510(k) number K033858.

Who is the listed applicant for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE?

The FDA 510(k) record lists European Custom Manufacturing BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE?

The FDA product code for TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE is LDF.

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.

Other records listing European Custom Manufacturing BV 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.

Related Devices (Code: LDF)

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.

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.

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