510(k) K881878
K881878 is an FDA 510(k) premarket notification submitted by Eris Medical Technology for the device "CATHETER WITHDRAWAL UNIT". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Eris Medical Technology has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1988
- Date Received
- May 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Catheter, G-U
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type