FDA 510(k)

8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER

K-Number: K910486 · 1991-04-19

Decision Date1991-04-19

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K910486. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER?

8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Davol, Inc.. The 510(k) number is K910486.

When did 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER receive FDA 510(k) clearance?

8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER received FDA 510(k) clearance on 1991-04-19, under 510(k) number K910486.

Who is the listed applicant for 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER?

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

What is the FDA product code for 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER?

The FDA product code for 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER is LJS.

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Other records listing Davol, Inc. as applicant

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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.