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FDA 510(k)

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH

K-Number: K933050 · 1993-12-14

ApplicantCritikon Company, LLC
Decision Date1993-12-14
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K933050. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH?

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Critikon Company, LLC. The 510(k) number is K933050.

When did CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH receive FDA 510(k) clearance?

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH received FDA 510(k) clearance on 1993-12-14, under 510(k) number K933050.

Who is the listed applicant for CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH?

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

What is the FDA product code for CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH?

The FDA product code for CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH is FOZ.

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Other records listing Critikon Company, LLC as applicant

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Related Devices (Code: FOZ)

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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.

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