510(k) K884337
K884337 is an FDA 510(k) premarket notification submitted by Catheter Research C/O Burditt, Bowles & Radzius for the device "MICRO-GUIDE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 1989. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Catheter Research C/O Burditt, Bowles & Radzius has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1989
- Date Received
- October 14, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1280
- Review Panel
- CV
- Submission Type