510(k) K910079
K910079 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "DISPOSABLE INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on February 27, 1991. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1991
- Date Received
- January 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type