GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE— 510(k) K945543
Substantially EquivalentIntersect Medical Products, Inc.
FDA 510(k) clearance K945543 for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE, Substantially Equivalent on 1994-11-29. Applicant: Intersect Medical Products, Inc..
Clearance details
- Applicant
- Intersect Medical Products, Inc.
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.