510(k) K863559
K863559 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL OCCLUSION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on October 10, 1986. The device falls under product code DQT (Occluder, Catheter Tip), a Class II device regulated under 21 CFR 870.1370. Uresil Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1986
- Date Received
- September 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Occluder, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.1370
- Review Panel
- CV
- Submission Type