510(k) K914984
K914984 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 20, 1992. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1992
- Date Received
- October 23, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type