FDA 510(k)

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE

K-Number: K890988 · 1989-08-25

Decision Date1989-08-25

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K890988. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE?

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Pace Medical. The 510(k) number is K890988.

When did MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE receive FDA 510(k) clearance?

MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE received FDA 510(k) clearance on 1989-08-25, under 510(k) number K890988.

Who is the listed applicant for MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE?

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

What is the FDA product code for MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE?

The FDA product code for MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE is LDF.

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Other records listing Pace Medical as applicant

K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V K002496MODEL 4815 ADAPTER K002497MODEL 4810 ANALYZER OUTPUT ADAPTER K001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528

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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.