510(k) K180994
K180994 is an FDA 510(k) premarket notification submitted by Interrad Medical, Inc. for the device "SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F". The FDA issued a decision of Substantially Equivalent on July 9, 2019. The device falls under product code KMK (Device, Intravascular Catheter Securement), a Class I device regulated under 21 CFR 880.5210. Interrad Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 2019
- Date Received
- April 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Intravascular Catheter Securement
- Device Class
- Class I
- Regulation Number
- 880.5210
- Review Panel
- HO
- Submission Type