510(k) K932218
K932218 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "CARDIAC CATH OR ANGIOGRAPHIC TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 27, 1993. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- August 27, 1993
- Date Received
- May 7, 1993
- 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