510(k) K013282
K013282 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on December 14, 2001. The device falls under product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5520. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2001
- Date Received
- October 2, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fab, Rhodamine, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5520
- Review Panel
- IM
- Submission Type