510(k) K173068
K173068 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Performer Introducer". The FDA issued a decision of Substantially Equivalent on Nov 17, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2017
- Date Received
- Sep 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)