510(k) K870413
K870413 is an FDA 510(k) premarket notification submitted by Medical Surgical Concepts, Inc. for the device "PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)". The FDA issued a decision of Substantially Equivalent on June 1, 1987. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Medical Surgical Concepts, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 1987
- Date Received
- February 3, 1987
- 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