510(k) K854910
K854910 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOFLOW". The FDA issued a decision of Substantially Equivalent on July 17, 1986. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1986
- Date Received
- December 9, 1985
- 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