510(k) K897075
K897075 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1990
- Date Received
- December 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type