510(k) K881781
K881781 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CATHETER STRAP". The FDA issued a decision of Substantially Equivalent on Aug 2, 1988. The device falls under product code KOD (Catheter, Urological), 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
- Aug 2, 1988
- Date Received
- Apr 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)