510(k) K935577
K935577 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ENTRE II PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on Feb 14, 1994. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 14, 1994
- Date Received
- Nov 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)