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FDA 510(k)

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)

K-Number: K960466 · 1996-05-29

ApplicantAbbott Laboratories
Decision Date1996-05-29
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-05-29 under 510(k) number K960466. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)?

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-05-29. The listed applicant is Abbott Laboratories. The 510(k) number is K960466.

When did IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) receive FDA 510(k) clearance?

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) received FDA 510(k) clearance on 1996-05-29, under 510(k) number K960466.

Who is the listed applicant for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)?

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

What is the FDA product code for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)?

The FDA product code for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) is LHI.

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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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