PeritX 1L Drainage Kit (90-1010) +12 more— 510(k) K241946

Clearance details

Device name as filed

PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-

Applicant

Bard Peripheral Vascular, Inc.

Product code

Code PNG

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2024-07-03

Decision date

2024-12-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tempe, AZ, US

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