510(k) K942191
K942191 is an FDA 510(k) premarket notification submitted by Uresil Corp. for the device "URESIL DILATOR". The FDA issued a decision of Substantially Equivalent on September 21, 1994. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Uresil Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1994
- Date Received
- May 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type