510(k) K964814
K964814 is an FDA 510(k) premarket notification submitted by Bipore, Inc. for the device "BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER". The FDA issued a decision of Substantially Equivalent on May 7, 1997. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Bipore, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1997
- Date Received
- November 29, 1996
- Clearance Type
- Traditional
- 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