510(k) K980795
K980795 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "UROLOGICAL BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on April 22, 1998. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1998
- Date Received
- March 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Catheter, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.5470
- Review Panel
- GU
- Submission Type