Decision Date2020-01-24
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Reprocessed Achieve Catheter Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2020-01-24 under 510(k) number K193263. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Reprocessed Achieve Catheter Connecting Cable?
Reprocessed Achieve Catheter Connecting Cable is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Innovative Health, LLC. The 510(k) number is K193263.
When did Reprocessed Achieve Catheter Connecting Cable receive FDA 510(k) clearance?
Reprocessed Achieve Catheter Connecting Cable received FDA 510(k) clearance on 2020-01-24, under 510(k) number K193263.
Who is the listed applicant for Reprocessed Achieve Catheter Connecting Cable?
The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed Achieve Catheter Connecting Cable?
The FDA product code for Reprocessed Achieve Catheter Connecting Cable is NLH.
Other records listing Innovative Health, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: NLH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.