510(k) K883174
K883174 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE". The FDA issued a decision of Substantially Equivalent on Oct 14, 1988. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 14, 1988
- Date Received
- Jul 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)