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Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

FDA product code PNG · 15 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5630
Review panel
GU
Implant
Yes
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2005-11-15 – 2025-01-14

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

PNG 2024-12-06

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.

K number K241946

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