510(k) K171081
K171081 is an FDA 510(k) premarket notification submitted by Rhythm Xience, Inc. (Rxi) for the device "Guider Catheter Introducer". The FDA issued a decision of Substantially Equivalent on May 9, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Rhythm Xience, Inc. (Rxi) has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2017
- Date Received
- Apr 11, 2017
- 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
- 510(k)