510(k) K181855
K181855 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "RadialSeal Introducer Kit". The FDA issued a decision of Substantially Equivalent on July 26, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Great Batch Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2018
- Date Received
- July 11, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type