Atlas FDA

PLEURX PERITONEAL CATHETER SYSTEM

FDA 510(k) clearance K113854 · decided 2012-03-19

Clearance details

K-number
K113854
Device name
PLEURX PERITONEAL CATHETER SYSTEM
Applicant
Care Fusion
Decision
Unknown
Date received
2011-12-29
Decision date
2012-03-19
Days to decision
81 days
Clearance type
Traditional
Product code
PNG
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Waukegan, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ASEPT® Glide Peritoneal Drainage System (K241278)Pfm Medical, Inc.2025-01-14
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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
ASPIRA PERITONEAL DRAINAGE SYSTEM (K110396)C.R. Bard, Inc.2011-05-06
ASEPT PERITONEAL DRAINAGE SYSTEM (K093796)Pfm Medical, Inc.2010-02-26

Recalls involving this device

No recalls on record reference this clearance.