510(k) K102540
K102540 is an FDA 510(k) premarket notification submitted by Great Batch Medical for the device "PTFE PORTABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on November 16, 2010. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Great Batch Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2010
- Date Received
- September 3, 2010
- 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