510(k) K914210
K914210 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "VAS-CATH DUALATOR(TM) VESSEL DILATOR". The FDA issued a decision of Substantially Equivalent on July 1, 1993. The device falls under product code FKA (Dilator, Vessel), a Class II device regulated under 21 CFR 876.5540. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1993
- Date Received
- September 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type