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FDA 510(k)

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE

K-Number: K941684 · 1994-08-03

ApplicantAbbott Laboratories
Decision Date1994-08-03
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-08-03 under 510(k) number K941684. The device is classified under product code FPB. 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?

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE is a medical device that received FDA 510(k) clearance on 1994-08-03. The listed applicant is Abbott Laboratories. The 510(k) number is K941684.

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

IVEX-2 EXTENSION SET WITH Y-INJECTION SITE received FDA 510(k) clearance on 1994-08-03, under 510(k) number K941684.

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

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?

The FDA product code for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE is FPB.

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Related Devices (Code: FPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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