MERIDIAN MEDICAL SYSTEMS BREATHING FILTER— 510(k) K925217
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K925217 for MERIDIAN MEDICAL SYSTEMS BREATHING FILTER, Substantially Equivalent on 1993-01-26. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CAH
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K925217
K-number listed on FDA's recall record- Z-0449-2026 — Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
- Z-3031-2024 — Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925217.
Data sourced from openFDA. This site is unofficial and independent of the FDA.