510(k) K030905
K030905 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "MEDAMICUS FLOWGUARD PEELABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on April 9, 2003. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medamicus, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2003
- Date Received
- March 24, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type