510(k) K930473
K930473 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "ONECATH L-CATH CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent - Kit with Drugs on Apr 7, 1994. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Luther Medical Products, Inc. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent - Kit with Drugs)
- Decision Date
- Apr 7, 1994
- Date Received
- Jan 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
- 510(k)