FDA 510(k)

MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.

K-Number: K896313 · 1990-03-06

Decision Date1990-03-06

Product CodeDTB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K896313. 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 IMPLANTABLE PACING LEADS W/IS-1 CONN.?

MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Medtronic Vascular. The 510(k) number is K896313.

When did MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. receive FDA 510(k) clearance?

MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. received FDA 510(k) clearance on 1990-03-06, under 510(k) number K896313.

Who is the listed applicant for MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.?

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 IMPLANTABLE PACING LEADS W/IS-1 CONN.?

The FDA product code for MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.