510(k) K172567
K172567 is an FDA 510(k) premarket notification submitted by W. L. Gore and Associates, Inc. for the device "GORE Molding and Occlusion Balloon Catheter". The FDA issued a decision of Substantially Equivalent on January 31, 2018. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. W. L. Gore and Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2018
- Date Received
- August 25, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular Occluding, Temporary
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type