510(k) K950155
K950155 is an FDA 510(k) premarket notification submitted by Cardio Vascular Concepts, Inc. for the device "RAPID-TRAK(TM) INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on August 2, 1995. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cardio Vascular Concepts, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1995
- Date Received
- January 17, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type