510(k) K885179
K885179 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD". The FDA issued a decision of Substantially Equivalent on Aug 9, 1989. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 9, 1989
- Date Received
- Dec 14, 1988
- 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
- 510(k)