510(k) K905083
K905083 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "4.5F IMAGECATH ANGIOSCOPE". The FDA issued a decision of Substantially Equivalent on Jun 21, 1991. The device falls under product code LYK (Angioscope), a Class II device regulated under 21 CFR 876.1500. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 1991
- Date Received
- Nov 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Angioscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- CV
- Submission Type
- 510(k)