Decision Date2016-04-05
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Disposable Temporary Pacing Cable is the device name listed in this FDA 510(k) record. The listed applicant is Tiger Medical Products. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K152947. 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 Disposable Temporary Pacing Cable?
Disposable Temporary Pacing Cable is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Tiger Medical Products. The 510(k) number is K152947.
When did Disposable Temporary Pacing Cable receive FDA 510(k) clearance?
Disposable Temporary Pacing Cable received FDA 510(k) clearance on 2016-04-05, under 510(k) number K152947.
Who is the listed applicant for Disposable Temporary Pacing Cable?
The FDA 510(k) record lists Tiger Medical Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Disposable Temporary Pacing Cable?
The FDA product code for Disposable Temporary Pacing Cable is DSA.
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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.