510(k) K991097
K991097 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "PBN DRAINAGE CATHETER GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on April 23, 1999. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1999
- Date Received
- April 1, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Catheter, G-U
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type