Atlas FDA

ASPIRA PERITONEAL DRAINAGE SYSTEM

FDA 510(k) clearance K110396 · decided 2011-05-06

Clearance details

K-number
K110396
Device name
ASPIRA PERITONEAL DRAINAGE SYSTEM
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2011-02-11
Decision date
2011-05-06
Days to decision
84 days
Clearance type
Special
Product code
PNG
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Salt Lake Ciy,, 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
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
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PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER (K122422)Care Fusion2012-10-24
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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
Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is i recall (Z-2959-2011)Bard Access Systems2011-08-08
Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is i recall (Z-2960-2011)Bard Access Systems2011-08-08
Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is i recall (Z-2961-2011)Bard Access Systems2011-08-08
Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainag recall (Z-2962-2011)Bard Access Systems2011-08-08

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01