Atlas FDA

PNG

15 FDA 510(k) clearances · Product code

141 daysmedian time to decision
291 days90th percentile
15clearances measured

FDA profile

Official device name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5630
Medical specialty
Gastroenterology, Urology
Flags
Implant · Life-sustaining
FDA definition
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Adverse events (MAUDE)
2021: 15 · 2022: 18 · 2023: 21 · 2024: 18 · 2025: 31 · 2026: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ASEPT® Glide Peritoneal Drainage System (K241278)Pfm Medical, Inc.2025-01-14
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- (K241946)Bard Peripheral Vascular, Inc.2024-12-06
Passio Pump Drainage System (K230319)Bearpac Medical2023-11-24
ASEPT Peritoneal Drainage System (K221779)Pfm Medical, Inc.2023-05-02
Aspira Peritoneal Drainage System (K212675)Merit Medical Systems, Inc.2021-12-14
PleurX Peritoneal Catheter System (K201155)Care Fusion2020-10-21
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (K162457)Rocket Medical Plc2016-11-14
PleurX Peritoneal Catheter System (K160437)Care Fusion2016-11-03
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (K152105)Rocket Medical Plc2016-03-29
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER (K122422)Care Fusion2012-10-24
PLEURX PERITONEAL CATHETER SYSTEM (K113854)Care Fusion2012-03-19
ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396)C.R. Bard, Inc.2011-05-06
ASEPT PERITONEAL DRAINAGE SYSTEM (K093796)Pfm Medical, Inc.2010-02-26
ASPIRA PERITONEAL DRAINAGE SYSTEM (K081288)C.R. Bard, Inc.2008-07-18
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS (K051711)Denver Biomedical, Inc.2005-11-15

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Every clearance here is in the API, with alerts when new ones post.