510(k) K042874
K042874 is an FDA 510(k) premarket notification submitted by Possis Medical, Inc. for the device "ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)". The FDA issued a decision of Substantially Equivalent on November 5, 2004. The device falls under product code QEZ (Aspiration Thrombectomy Catheter), a Class II device regulated under 21 CFR 870.5150. Possis Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2004
- Date Received
- October 18, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aspiration Thrombectomy Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.