510(k) K041338
K041338 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 19, 2004. The device falls under product code MWS (Stabilizer, Heart), a Class I device regulated under 21 CFR 870.4500. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2004
- Date Received
- May 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stabilizer, Heart
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type