510(k) K992174
K992174 is an FDA 510(k) premarket notification submitted by Pilling Weck Surgical for the device "PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP". The FDA issued a decision of Substantially Equivalent on March 23, 2000. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Pilling Weck Surgical has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2000
- Date Received
- June 28, 1999
- 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