510(k) K913364
K913364 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED 7 FR. & 8 FR.". The FDA issued a decision of Substantially Equivalent on Aug 30, 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
- Aug 30, 1991
- Date Received
- Jul 29, 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
- 510(k)