510(k) K842577
K842577 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "CATH-TECH POLYURETHANE UMBILICAL VESS". The FDA issued a decision of Substantially Equivalent on March 13, 1985. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1985
- Date Received
- July 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type