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FDA 510(k)

LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)

K-Number: K801284 · 1980-12-01

ApplicantMedtronic Vascular
Decision Date1980-12-01
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1980-12-01 under 510(k) number K801284. 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 LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)?

LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) is a medical device that received FDA 510(k) clearance on 1980-12-01. The listed applicant is Medtronic Vascular. The 510(k) number is K801284.

When did LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) receive FDA 510(k) clearance?

LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) received FDA 510(k) clearance on 1980-12-01, under 510(k) number K801284.

Who is the listed applicant for LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)?

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

What is the FDA product code for LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)?

The FDA product code for LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) is DTB.

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Other records listing Medtronic Vascular as applicant

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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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