510(k) K991027
K991027 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "BI-DIRECTIONAL TUNNELER". The FDA issued a decision of Substantially Equivalent on April 22, 1999. 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. Impra, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1999
- Date Received
- March 29, 1999
- Clearance Type
- Special
- 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