Aspira Peritoneal Drainage System— 510(k) K212675

Clearance details

Applicant

Merit Medical Systems, Inc.

Product code

Code PNG

Device class

Class 2

Regulation

21 CFR 876.5630

Advisory panel

Gastroenterology, Urology

Date received

2021-08-24

Decision date

2021-12-14

Decision

Unknown

Clearance type

Special

Location

South Jordan, UT, US

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• 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 K212675.