510(k) K834477
K834477 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "DISPOS. SCOTT CANNULAS 16-1054 ETC.". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code HCA (Catheter, Ventricular), a Class II device regulated under 21 CFR 882.4100. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1984
- Date Received
- December 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ventricular
- Device Class
- Class II
- Regulation Number
- 882.4100
- Review Panel
- NE
- Submission Type