510(k) K821220
K821220 is an FDA 510(k) premarket notification submitted by Clincal Instruments Corp. for the device "MULTILUMEN INTRAVENOUS INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on July 9, 1982. The device falls under product code GBP (Catheter, Multiple Lumen), a Class I device regulated under 21 CFR 878.4200. Clincal Instruments Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 9, 1982
- Date Received
- April 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Multiple Lumen
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type