510(k) K931403
K931403 is an FDA 510(k) premarket notification submitted by Dymax Corp for the device "SITERITE NEEDLE GUIDE (MODIFIED)". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Dymax Corp has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1993
- Date Received
- March 19, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type