510(k) K925403

BAXTER APD 12' EXTENSION LINE by Baxter Healthcare Corp — Product Code KDJ

K925403 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER APD 12' EXTENSION LINE". The FDA issued a decision of Substantially Equivalent on Feb 22, 1994. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 22, 1994
Date Received
Oct 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type
510(k)

Source: FDA 510(k) database entry for K925403. Report a data issue: hello@regdatalab.com.