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FDA 510(k)

MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS

K-Number: K913288 · 1991-10-17

ApplicantMedtronic Vascular
Decision Date1991-10-17
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1991-10-17 under 510(k) number K913288. 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 MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS?

MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS is a medical device that received FDA 510(k) clearance on 1991-10-17. The listed applicant is Medtronic Vascular. The 510(k) number is K913288.

When did MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS receive FDA 510(k) clearance?

MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS received FDA 510(k) clearance on 1991-10-17, under 510(k) number K913288.

Who is the listed applicant for MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS?

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 MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS?

The FDA product code for MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS is DTB.

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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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