510(k) K950534
K950534 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED SCEPTOR PTCA GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on Apr 28, 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
- Apr 28, 1995
- Date Received
- Feb 7, 1995
- 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)