510(k) K905499
K905499 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMD 7 FR. TRIGUIDE GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on Feb 11, 1991. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 1991
- Date Received
- Dec 7, 1990
- 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
- 510(k)