Nipro Safetouch Tulip Safety Fistula Needle
FDA 510(k) K071145 · Nipro Medical Corporation
510(k) numberK071145
Submission
- Device name
- Nipro Safetouch Tulip Safety Fistula Needle
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- April 24, 2007
- Decision date
- September 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
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| K212677 | aboNT SYRINGEFMF · Traditional | 04/15/2022SE |
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| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | 07/19/2019SE |
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Questions and answers
When was Nipro Safetouch Tulip Safety Fistula Needle cleared by the FDA?
Nipro Safetouch Tulip Safety Fistula Needle (K071145) received a 510(k) decision of Substantially Equivalent on September 7, 2007, 136 days after the submission was received.
What is the product code of K071145?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.