510(k) K041727
K041727 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456". The FDA issued a decision of Substantially Equivalent on July 23, 2004. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2004
- Date Received
- June 25, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.