510(k) K841828
K841828 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "CENTRAL VENOUS CATHETER W/BIG-GARD". The FDA issued a decision of Substantially Equivalent on July 13, 1984. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1984
- Date Received
- May 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type