510(k) K043525
K043525 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "CATHETER INTRODUCER". The FDA issued a decision of Substantially Equivalent on February 9, 2005. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Galt Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2005
- Date Received
- December 21, 2004
- 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