510(k) K943349
K943349 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "MAHURKAR DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on March 22, 1995. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 22, 1995
- Date Received
- July 12, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type