FDA 510(k)

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR

K-Number: K801355 · 1980-07-08

Decision Date1980-07-08

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801355. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR?

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Cordis Corp.. The 510(k) number is K801355.

When did BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR receive FDA 510(k) clearance?

BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801355.

Who is the listed applicant for BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR?

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

What is the FDA product code for BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR?

The FDA product code for BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR is KOC.

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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.