510(k) K922567
K922567 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "LOW PROFILE CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on November 21, 1995. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Rusch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 21, 1995
- Date Received
- June 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type