FDA 510(k)

MODIFICATION OF JELCO,JELCO-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT

K-Number: K990236 · 1999-08-20

ApplicantJohnson & Johnson Medical, Div. of Ethicon, Inc.

Decision Date1999-08-20

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. It received FDA 510(k) clearance on 1999-08-20 under 510(k) number K990236. 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 MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT?

MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT is a medical device that received FDA 510(k) clearance on 1999-08-20. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. The 510(k) number is K990236.

When did MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT receive FDA 510(k) clearance?

MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT received FDA 510(k) clearance on 1999-08-20, under 510(k) number K990236.

Who is the listed applicant for MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT?

The FDA 510(k) record lists Johnson & Johnson Medical, Div. of Ethicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT?

The FDA product code for MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT is FOZ.

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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.