FDA 510(k)

ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493

K-Number: K961825 · 1996-08-06

Decision Date1996-08-06

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K961825. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493?

ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K961825.

When did ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 receive FDA 510(k) clearance?

ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 received FDA 510(k) clearance on 1996-08-06, under 510(k) number K961825.

Who is the listed applicant for ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493?

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

What is the FDA product code for ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493?

The FDA product code for ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 is KDJ.

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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.