Decision Date1992-12-23
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MODEL 4280 SURGICAL EXTENSION CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Pace Medical. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K922899. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MODEL 4280 SURGICAL EXTENSION CABLE?
MODEL 4280 SURGICAL EXTENSION CABLE is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Pace Medical. The 510(k) number is K922899.
When did MODEL 4280 SURGICAL EXTENSION CABLE receive FDA 510(k) clearance?
MODEL 4280 SURGICAL EXTENSION CABLE received FDA 510(k) clearance on 1992-12-23, under 510(k) number K922899.
Who is the listed applicant for MODEL 4280 SURGICAL EXTENSION CABLE?
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 4280 SURGICAL EXTENSION CABLE?
The FDA product code for MODEL 4280 SURGICAL EXTENSION CABLE is DSA.
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Other records listing Pace Medical as applicant
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K011980ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825K012392DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260K002204PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265VK002497MODEL 4810 ANALYZER OUTPUT ADAPTERK002496MODEL 4815 ADAPTERK001180TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 View all 19 devices →
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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.