510(k) K980278
K980278 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL VASCU-FLO INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Uresil Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1998
- Date Received
- January 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type