510(k) K960917
K960917 is an FDA 510(k) premarket notification submitted by Scientific Device Manufacturer, LLC for the device "PERCUGLIDE". The FDA issued a decision of Substantially Equivalent on July 2, 1996. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Scientific Device Manufacturer, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1996
- Date Received
- March 6, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type