SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F— 510(k) K180994
Substantially EquivalentInterrad Medical, Inc.
FDA 510(k) clearance K180994 for SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F, Substantially Equivalent on 2019-07-09. Applicant: Interrad Medical, Inc..
Clearance details
- Applicant
- Interrad Medical, Inc.
- Product code
- Code KMK
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Adverse events under product code KMK
product code KMK- Malfunction
- 461
- Other
- 1
- Total
- 462
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.