510(k) K946180
K946180 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED(R) ENTRE PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on Mar 17, 1995. 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
- Mar 17, 1995
- Date Received
- Dec 20, 1994
- 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)