510(k) K170616
K170616 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "van Andel Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Apr 28, 2017. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2017
- Date Received
- Mar 1, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type
- 510(k)