510(k) K021210
K021210 is an FDA 510(k) premarket notification submitted by Arteria Medical Science, Inc. for the device "ARTERIA OCCLUSION BALLOON". The FDA issued a decision of Substantially Equivalent on October 28, 2002. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Arteria Medical Science, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2002
- Date Received
- April 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular Occluding, Temporary
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type