510(k) K950813
K950813 is an FDA 510(k) premarket notification submitted by Cardio Vascular Concepts, Inc. for the device "MOLLRING CUTTER". The FDA issued a decision of Substantially Equivalent on July 25, 1995. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Cardio Vascular Concepts, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1995
- Date Received
- February 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stripper, Artery, Intraluminal
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type