510(k) K914979
K914979 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "EDM(R) INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on September 16, 1992. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Peripheral Systems Group has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1992
- Date Received
- November 6, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type