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FDA 510(k)

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

K-Number: K900984 · 1990-05-03

ApplicantMedtronic Vascular
Decision Date1990-05-03
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1990-05-03 under 510(k) number K900984. 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 MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1?

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 is a medical device that received FDA 510(k) clearance on 1990-05-03. The listed applicant is Medtronic Vascular. The 510(k) number is K900984.

When did MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 receive FDA 510(k) clearance?

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 received FDA 510(k) clearance on 1990-05-03, under 510(k) number K900984.

Who is the listed applicant for MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1?

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 MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1?

The FDA product code for MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 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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