510(k) K980870
K980870 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SILICONE FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on June 9, 1998. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Rusch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1998
- Date Received
- March 4, 1998
- 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