510(k) K842147
K842147 is an FDA 510(k) premarket notification submitted by Catheter Technology Corp. for the device "CATH-TECH CHOLANGIOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on October 2, 1984. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Catheter Technology Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1984
- Date Received
- May 30, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type