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FDA 510(k)

LATIS GRAFT CLEANING CATHETER

K-Number: K973465 · 1998-02-19

Decision Date1998-02-19
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LATIS GRAFT CLEANING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1998-02-19 under 510(k) number K973465. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATIS GRAFT CLEANING CATHETER?

LATIS GRAFT CLEANING CATHETER is a medical device that received FDA 510(k) clearance on 1998-02-19. The listed applicant is Applied Medical Resources. The 510(k) number is K973465.

When did LATIS GRAFT CLEANING CATHETER receive FDA 510(k) clearance?

LATIS GRAFT CLEANING CATHETER received FDA 510(k) clearance on 1998-02-19, under 510(k) number K973465.

Who is the listed applicant for LATIS GRAFT CLEANING CATHETER?

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

What is the FDA product code for LATIS GRAFT CLEANING CATHETER?

The FDA product code for LATIS GRAFT CLEANING CATHETER is DXE.

Related Clinical Trials

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.

Other records listing Applied Medical Resources 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.

View all 53 devices →

Related Devices (Code: DXE)

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.

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.

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