FDA 510(k)

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381

K-Number: K884554 · 1989-01-31

Decision Date1989-01-31

Product CodeFKX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 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 1989-01-31 under 510(k) number K884554. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERITONEAL CATHETER STABILIZATION DEVICE 5C4381?

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 is a medical device that received FDA 510(k) clearance on 1989-01-31. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K884554.

When did PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 receive FDA 510(k) clearance?

PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 received FDA 510(k) clearance on 1989-01-31, under 510(k) number K884554.

Who is the listed applicant for PERITONEAL CATHETER STABILIZATION DEVICE 5C4381?

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 PERITONEAL CATHETER STABILIZATION DEVICE 5C4381?

The FDA product code for PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 is FKX.

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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.