FDA 510(k)

ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS

K-Number: K890527 · 1989-04-21

Decision Date1989-04-21

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1989-04-21 under 510(k) number K890527. 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 ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS?

ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS is a medical device that received FDA 510(k) clearance on 1989-04-21. The listed applicant is Medtronic Vascular. The 510(k) number is K890527.

When did ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS receive FDA 510(k) clearance?

ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS received FDA 510(k) clearance on 1989-04-21, under 510(k) number K890527.

Who is the listed applicant for ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS?

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 ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS?

The FDA product code for ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS is DTB.

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Related Devices (Code: DTB)

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 Vascular K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

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.