Submission Details
| 510(k) Number | K181175 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | May 02, 2018 |
| Decision Date | July 05, 2018 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
12F Tri-Flow Triple Lumen Catheter
Jul 2018
Decision
64d
Days
Class 2
Risk
About This 510(k) Submission
K181175 is an FDA 510(k) clearance for the 12F Tri-Flow Triple Lumen Catheter, a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II — Special Controls, product code NIE), submitted by Medical Components, Inc. (dba MedComp) (Harleysville, US). The FDA issued a Cleared decision on July 5, 2018, 64 days after receiving the submission on May 2, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
Device Classification
| Product Code | NIE — Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion. |
Manufacturer
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