510(k) K890182
K890182 is an FDA 510(k) premarket notification submitted by Aesculap Instruments Corp. for the device "PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV". The FDA issued a decision of Substantially Equivalent on February 28, 1990. 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. Aesculap Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1990
- Date Received
- January 18, 1989
- 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