510(k) K895437
K895437 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED CORONARY GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on Jun 28, 1990. 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
- Jun 28, 1990
- Date Received
- Sep 8, 1989
- 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)