72 HOUR USE TRACH CARE WITH MICROBAN— 510(k) K974630
Substantially EquivalentBallard Medical Products
FDA 510(k) clearance K974630 for 72 HOUR USE TRACH CARE WITH MICROBAN, Substantially Equivalent on 1998-03-11. Applicant: Ballard Medical Products. Device class: 2.
Clearance details
- Applicant
- Ballard Medical Products
- 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
- Draper, UT, US
Recent devices under product code CAH
view allMore clearances from Ballard Medical Products
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.