ASPIRA PERITONEAL DRAINAGE SYSTEM— 510(k) K110396

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code PNG

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2011-02-11

Decision date

2011-05-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Salt Lake Ciy,, UT, US

• K241278 — ASEPT® Glide Peritoneal Drainage System2025-01-14
• K241946 — PeritX 1L Drainage Kit (90-1010) +12 more2024-12-06
• K230319 — Passio Pump Drainage System2023-11-24
• K221779 — ASEPT Peritoneal Drainage System2023-05-02
• K212675 — Aspira Peritoneal Drainage System2021-12-14

• K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
• K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit2026-05-29
• K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)2026-03-17
• K251864 — Rubber Utility Catheter2026-02-23
• K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)2025-05-15

• Z-1908-2023 — Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1909-2023 — Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1910-2023 — Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1911-2023 — Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1912-2023 — Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1913-2023 — Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1914-2023 — Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1915-2023 — Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1916-2023 — Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx OnlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1917-2023 — Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution onlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1918-2023 — Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution onlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1919-2023 — Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution onlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422
• Z-1920-2023 — Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution onlyClass II·Ongoing·Merit Medical Systems, Inc.·20230422

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110396.