510(k) K895868
K895868 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE". The FDA issued a decision of Substantially Equivalent on Oct 31, 1989. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 31, 1989
- Date Received
- Oct 4, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Instrument, Shunt System Implantation
- Device Class
- Class I
- Regulation Number
- 882.4545
- Review Panel
- NE
- Submission Type
- 510(k) Exempt