510(k) K143738
K143738 is an FDA 510(k) premarket notification submitted by Intuit Medical Products, LLC for the device "DSS Sinusplasty Balloon Catheter". The FDA issued a decision of Substantially Equivalent on August 27, 2015. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420. Intuit Medical Products, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2015
- Date Received
- December 30, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ent Manual Surgical
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type