510(k) K955588
K955588 is an FDA 510(k) premarket notification submitted by Carbomedics, Inc. for the device "VASCUTEK GRAFT SIZER SET". The FDA issued a decision of ST on March 7, 1996. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Carbomedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- March 7, 1996
- Date Received
- December 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type