510(k) K854511
K854511 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET". The FDA issued a decision of Substantially Equivalent on February 10, 1986. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1986
- Date Received
- November 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type