FDA 510(k)

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET

K-Number: K801356 · 1980-07-08

Decision Date1980-07-08

Product CodeKOC

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET 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 K801356. 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 SAFE(DOUBLE LUMEN CATHET?

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET 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 K801356.

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

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801356.

Who is the listed applicant for BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET?

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 SAFE(DOUBLE LUMEN CATHET?

The FDA product code for BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET is KOC.

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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.