510(k) K944007
K944007 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EUROPHILIC SLIPPERY COATED FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on Jun 29, 1995. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 1995
- Date Received
- Aug 16, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)