510(k) K991647
K991647 is an FDA 510(k) premarket notification submitted by Tfx Medical Group for the device "TFX MEDICAL INTRODUCER KIT". The FDA issued a decision of Substantially Equivalent on January 4, 2000. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Tfx Medical Group has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2000
- Date Received
- May 13, 1999
- 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