PROGUIDE CHRONIC DIALYSIS CATHETER— 510(k) K090148
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K090148 for PROGUIDE CHRONIC DIALYSIS CATHETER, Substantially Equivalent on 2009-04-13. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code MSD
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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 K090148
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090148.
Data sourced from openFDA. This site is unofficial and independent of the FDA.