Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter
FDA 510(k) K120674 · Covidien
510(k) numberK120674
Submission
- Device name
- Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter
- Applicant
- Covidien
Mansfield, MA, US - Received
- March 5, 2012
- Decision date
- April 4, 2012
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MPB – Catheter, Hemodialysis, Non-Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K102833 | Disposable Hemodialysis Access Catheter SetsMPB · Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 11/18/2011SE |
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Questions and answers
When was Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter cleared by the FDA?
Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen Catheter (K120674) received a 510(k) decision of Unknown on April 4, 2012, 30 days after the submission was received.
What is the product code of K120674?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.