Atlas FDA

Aspira Peritoneal Drainage System

FDA 510(k) clearance K212675 · decided 2021-12-14

Clearance details

K-number
K212675
Device name
Aspira Peritoneal Drainage System
Applicant
Merit Medical Systems, Inc.
Decision
Unknown
Date received
2021-08-24
Decision date
2021-12-14
Days to decision
112 days
Clearance type
Special
Product code
PNG
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
South Jordan, UT, 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
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
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

Recalls involving this device

RecordFirmDate
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile E recall (Z-1908-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile E recall (Z-1909-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile E recall (Z-1910-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile E recall (Z-1911-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, recall (Z-1912-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, recall (Z-1913-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, recall (Z-1914-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO recall (Z-1915-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only recall (Z-1916-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distri recall (Z-1917-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Dist recall (Z-1918-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distri recall (Z-1919-2023)Merit Medical Systems, Inc.2023-06-14
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Dist recall (Z-1920-2023)Merit Medical Systems, Inc.2023-06-14

PMA approvals by this applicant

RecordFirmDate
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004)Merit Medical Systems, Inc.2025-12-11
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001)Merit Medical Systems, Inc.2025-02-12
WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002)Merit Medical Systems, Inc.2025-02-12
WRAPSODY® Cell-Impermeable Endoprosthesis (P240023)Merit Medical Systems, Inc.2024-12-19