510(k) K874242
K874242 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "JEHLE CORONARY PERFUSION CATHETERS". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Pilling Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1987
- Date Received
- October 16, 1987
- 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