510(k) K963320
K963320 is an FDA 510(k) premarket notification submitted by Tfx Medical Group for the device "TFX MEDICAL GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on December 3, 1996. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Tfx Medical Group has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1996
- Date Received
- August 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type