510(k) K913397
K913397 is an FDA 510(k) premarket notification submitted by Mega Medical, Inc. for the device "MEGA ANGIOGRAM KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on October 31, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Mega Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- October 31, 1991
- Date Received
- July 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type